Data / Medical devices / United States / Procedure Products, Inc.
Procedure Products, Inc.: FDA-registered device maker in Vancouver, WA, United States, 10 510(k) clearances
Procedure Products, Inc. is registered with the FDA (registration 3020778) in Vancouver, WA, United States. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 27, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020778
- Address
- 1801 West 4TH Plain BLVD., Vancouver, WA, United States, 98660
- Owner or operator
- Procedure Products, Inc. (3020778)
- Roles
- Manufacturer
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- ! way - 3 way Lock - Slip - Fixed - Configurations, 05cc/ml, 10cc/ml and 20cc/ml Plungers for standard BD size barrels and stoppers, 10¿, 12¿, 15¿, 20¿ 24¿, 30¿, 36¿, 48¿, 60¿ and 72¿ Lengths, 1200 PSI, 1000 PSI, 500 PSI and below, 16oz cups, 3016-color, 2oz cups, 3002-color, 32oz cups, 3032-color, 4502 - Waste Bag System with Dual Check Valve Bonded and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | 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 |
|---|---|---|---|---|---|---|
| March 27, 2017 | K161812 | Freedom Syringe | FMF | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| December 10, 1992 | K922536 | TORQUE DEVICE | DQX | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| November 27, 1991 | K914128 | CONNECTING SET | DQO | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| April 24, 1991 | K910673 | BAG SPIGOT | KPE | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| December 20, 1988 | K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | FMF | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| February 4, 1988 | K874747 | 10CC SYRINGE CONTROL RING SET | FMF | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| January 29, 1988 | K874037 | ANGIO WASTE FLUIDS DUMP BAG | DQO | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| September 5, 1984 | K842173 | DISPOSABLE STOPCOCKS | FMG | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| May 21, 1981 | K810921 | MALE LUER LOCK PLUGS | FPA | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
| April 11, 1981 | K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL | DRE | Substantially Equivalent | Procedure Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 27, 2015 | 72596 | Class II | Terminated | U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring | The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Liquid Medication, Graduated
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Syringe, Piston
- All makers of Wire, Guide, Catheter
- All makers of Container, I.V.
- All makers of Set, Administration, Intravascular
Updated March 27, 2017. 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.