NAMIC ANGIOGRAPHIC SYRINGE
FDA 510(k) clearance K873955 · decided 1988-02-05
Clearance details
- K-number
- K873955
- Device name
- NAMIC ANGIOGRAPHIC SYRINGE
- Applicant
- North American Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-28
- Decision date
- 1988-02-05
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Glens Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU recall (Z-1712-2026) | Medline Industries, LP | 2026-04-07 |