Procedure Products, Inc.
Vancouver, WA, US
PROCEDURE PRODUCTS, INC. appears in FDA device records in Vancouver, WA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Procedure Products, Inc. between 1981 and 2017. The busiest year on record is 1981, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 4 |
| 1982 | 1 |
| 1984 | 2 |
| 1986 | 1 |
| 1988 | 3 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161812 | Freedom Syringe | FMF | Substantially Equivalent | |
| K923194 | INSUFFLATOR CONNECTING FILTER | HIF | Substantially Equivalent | |
| K922536 | TORQUE DEVICE | DQX | Substantially Equivalent | |
| K914128 | CONNECTING SET | DQO | Substantially Equivalent | |
| K910673 | BAG SPIGOT | KPE | Substantially Equivalent | |
| K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | FMF | Substantially Equivalent | |
| K874747 | 10CC SYRINGE CONTROL RING SET | FMF | Substantially Equivalent | |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | DQO | Substantially Equivalent | |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | DTL | Substantially Equivalent | |
| K842173 | DISPOSABLE STOPCOCKS | FMG | Substantially Equivalent | |
| K833554 | MATERIAL ADDITION LEXAN & K-RESIN | DQO | Substantially Equivalent | |
| K820384 | GLASS SYRINGES, DRUG, LUER LOCK | FMF | Substantially Equivalent | |
| K812657 | INJECTION CAP, LUER LOCK | FPA | Substantially Equivalent | |
| K811548 | CERVICAL SPATULA | HHT | Substantially Equivalent | |
| K810921 | MALE LUER LOCK PLUGS | FPA | Substantially Equivalent | |
| K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL | DRE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020778 | 3020778 | PROCEDURE PRODUCTS, INC. | 1801 WEST 4TH PLAIN BLVD., Vancouver, WA 98660 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- DQOCatheter, Intravascular, Diagnostic
- KPEContainer, I.V.
- KYWContainer, Liquid Medication, Graduated
- DREDilator, Vessel, For Percutaneous Catheterization
- HIFInsufflator, Laparoscopic
- FPASet, Administration, Intravascular
- HHTSpatula, Cervical, Cytological
- FMGStopcock, I.V. Set
- FMFSyringe, Piston
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0355-2016 | 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 in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization. | The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Procedure Products, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain