Procedure Products, Inc.
Medical device manufacturer in Vancouver, WA.
16510(k) clearances
0PMA approvals
1recalls
Device types
- FMF Syringe, Piston 4
- DQO Catheter, Intravascular, Diagnostic 3
- FPA Set, Administration, Intravascular 2
- DRE Dilator, Vessel, For Percutaneous… 1
- HHT Spatula, Cervical, Cytological 1
- FMG Stopcock, I.V. Set 1
- DTL Adaptor, Stopcock, Manifold, Fitting… 1
- KPE Container, I.V. 1
- DQX Wire, Guide, Catheter 1
- HIF Insufflator, Laparoscopic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K161812 | Freedom SyringeFMF · Abbreviated | 03/27/2017SE |
| K923194 | Insufflator Connecting FilterHIF · Traditional | 10/08/1993SE |
| K922536 | Torque DeviceDQX · Traditional | 12/10/1992SE |
| K914128 | Connecting SetDQO · Traditional | 11/27/1991SE |
| K910673 | Bag SpigotKPE · Traditional | 04/24/1991SE |
| K884985 | Modified 10CC Syringe Control Ring SetFMF · Traditional | 12/20/1988SE |
| K874747 | 10CC Syringe Control Ring SetFMF · Traditional | 02/04/1988SE |
| K874037 | Angio Waste Fluids Dump BagDQO · Traditional | 01/29/1988SE |
| K853749 | Custom Coronary Manifold KitsDTL · Traditional | 01/13/1986SE |
| K842173 | Disposable StopcocksFMG · Traditional | 09/05/1984SE |
| K833554 | Material Addition Lexan & K-ResinDQO · Traditional | 03/12/1984SE |
| K820384 | Glass Syringes, Drug, Luer LockFMF · Traditional | 04/15/1982SE |
| K812657 | Injection Cap, Luer LockFPA · Traditional | 10/23/1981SE |
| K811548 | Cervical SpatulaHHT · Traditional | 06/23/1981SE |
| K810921 | Male Luer Lock PlugsFPA · Traditional | 05/21/1981SE |
| K810859 | Single Use Seldinger/Cournand Perc. NDLDRE · Traditional | 04/11/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0355-2016 Class II | U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in…The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire… | 10/27/2015Terminated |