Primeline Medical Products, Inc.
Edmonton, Alberta, CA
Primeline Medical Products, Inc. appears in FDA device records in Edmonton, Alberta, CA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Primeline Medical Products, Inc. between 1997 and 2002. The busiest year on record is 2002, with 5. The most recent is 2002, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023266 | PRIMAGARD SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K023117 | PRIMAGARD SURGICAL GOWNS | KKX | Substantially Equivalent | |
| K022868 | PRIMAGARD SURGICAL EQUIPMENT DRAPES | KKX | Substantially Equivalent | |
| K021864 | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | KKX | Substantially Equivalent | |
| K021076 | PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM | FXX | Substantially Equivalent | |
| K011789 | PROCEDURE MASKS: PM4-301 AND PM4-304 | FXX | Substantially Equivalent | |
| K001951 | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | FXX | Substantially Equivalent | |
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | FXP | Substantially Equivalent | |
| K971075 | PRIMED PRIME-PLUS COTTON GAUZE SPONGES | EFQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain