Data / Medical devices / United States / KDL Medical, Inc.
KDL Medical, Inc.: FDA-registered device maker in Richardson, TX, United States, 2 510(k) clearances
KDL Medical, Inc. is registered with the FDA (registration 1649139) in Richardson, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1649139
- FEI number
- 3002406063
- Address
- 800 E Campbell Rd Ste 252, Richardson, TX, United States, 75081
- Owner or operator
- KDL MEDICAL, INC. dba CHASE MEDICAL (9028011)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 6, 1997
- Registered through
- 2026
- Brand names listed
- Blower Mister, Disposable Platform Blades, FASTRACT Sternal Retractor, FASTRACT Suture Stay - Pair, FASTRACT Suture Stay - Single, OPHIDIA Vacuum Heart Stabilizer, TRIPOD Heart Stabilizer Lt Metal FASTRACT, TRIPOD Heart Stabilizer Lt Metal w/Occluder and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 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 |
|---|---|---|---|---|---|---|
| January 6, 1998 | K974568 | CHASE ANASTOMOSIS VISUALIZATION DEVICE | FQH | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
| August 22, 1997 | K972665 | CHASE BLOOD VESSEL SHUNT | DWF | Substantially Equivalent | Chase Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Instruments, Surgical, Cardiovascular
- All makers of Lavage, Jet
Updated January 6, 1998. 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.