Data / Medical devices / United States / Primrose Medical, Inc.
Primrose Medical, Inc.: FDA-registered device maker in East Walpole, MA, United States, 6 510(k) clearances
Primrose Medical, Inc. is registered with the FDA (registration 1220905) in East Walpole, MA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 8, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1220905
- Address
- 286 Union Street, East Walpole, MA, United States, 02032
- Owner or operator
- PRIMROSE MEDICAL INC. (1220905)
- Roles
- Manufacturer
- First device listed
- January 21, 2011
- Registered through
- 2026
- Brand names listed
- Iv Cath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 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 |
|---|---|---|---|---|---|---|
| September 8, 2003 | K021471 | MARQUETTE HUBER TRAP SAFETY INFUSION SET | FPA | Substantially Equivalent | Marquette Medical, Inc. | accessdata.fda.gov |
| October 13, 1992 | K920537 | SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | Marquette Medical, Inc. | accessdata.fda.gov |
| October 17, 1988 | K884211 | STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES | FMI | Substantially Equivalent | Marquette Medical, Inc. | accessdata.fda.gov |
| August 4, 1988 | K881976 | CATHETER, INTRAVASCULAR | FOZ | Substantially Equivalent | Primrose Medical, Inc. | accessdata.fda.gov |
| July 29, 1988 | K881975 | SET, INTRAVASCULAR | FPA | Substantially Equivalent | Primrose Medical, Inc. | accessdata.fda.gov |
| September 24, 1987 | K873493 | NINJA SCALPEL | GES | Substantially Equivalent | Primrose Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Blade, Scalpel
- All makers of Set, Administration, Intravascular
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Port & Catheter, Implanted, Subcutaneous, Intravascular
Updated September 8, 2003. 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.