Data / Medical devices / United States / Cook Vandergrift Inc.
Cook Vandergrift Inc.: FDA-registered device maker in Vandergrift, PA, United States, 12 510(k) clearances
Cook Vandergrift Inc. is registered with the FDA (registration 2522007) in Vandergrift, PA, United States. It lists 8 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 18, 2017. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2522007
- Address
- 1186 Montgomery Lane, Vandergrift, PA, United States, 15690
- Owner or operator
- COOK VANDERGRIFT INC. (2522007)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 12, 2005
- Registered through
- 2027
- Brand names listed
- Bulldog Lead Extender, Byrd Dilator Sheath Set - Extra Long Polypropylene, Byrd Dilator Sheath Set - Polypropylene, Byrd Telescoping Stainless Steel Sheath Set, Coil Expander, Curved 16 Fr Introducer Set - Femoral, Curved Inner Femoral Sheath, Dilator Sheath Sets and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Embolectomy | DXE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Catheter | GCC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stylet, Catheter | DRB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2017 | K170298 | Liberator Beacon Tip Locking Stylet | DRB | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| July 11, 2017 | K163353 | Needle's Eye Snare Retrieval Set - 54cm | DXE | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 8, 2016 | K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | MQH | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 18, 2015 | K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | MQH | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| November 12, 2014 | K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | DRE | Substantially Equivalent | Cook Vascular, Inc. | accessdata.fda.gov |
| July 1, 2014 | K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE | Substantially Equivalent | Cook Vascular, Inc. | accessdata.fda.gov |
| January 16, 2004 | K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | MQH | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| January 16, 2004 | K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, | MQH | Substantially Equivalent | Cook Urological, Inc. | accessdata.fda.gov |
| December 27, 1996 | K961992 | NEEDLE'S EYE SNARE | DXE | Substantially Equivalent | Cook Pacemaker Corp. | accessdata.fda.gov |
| July 30, 1992 | K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | GCC | Substantially Equivalent | Med Institute, Inc. | accessdata.fda.gov |
| January 3, 1992 | K914555 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) | DRE | Substantially Equivalent | Med Institute, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893480 | BYRD EXTRACTOR SET | GCC | Substantially Equivalent | Medical Engineering and Development Institute | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 24, 2023 | 92791 | Class II | Ongoing | Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001 | Sterility of device may be compromised due to breach of the chevron seal of the packaging | accessdata.fda.gov |
| November 28, 2017 | 79425 | Class II | Terminated | Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for i | Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not | accessdata.fda.gov |
| April 24, 2008 | 48642 | Not yet classified | Terminated | Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter | Mislabeled - wrong size catheter was packaged in the box | accessdata.fda.gov |
| March 2, 2008 | 48629 | Not yet classified | Terminated | Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes. | mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | accessdata.fda.gov |
| December 17, 2007 | 48630 | Not yet classified | Terminated | Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes. | mislabeled - 300 micron flexipets were labeled as 80 microns | accessdata.fda.gov |
Compare with other makers
- All makers of Microtools, Assisted Reproduction (Pipettes)
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Dilator, Catheter
- All makers of Catheter, Embolectomy
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Stylet, Catheter
Updated September 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.