MORSE DT MANIFOLD
FDA 510(k) clearance K902472 · decided 1990-08-23
Clearance details
- K-number
- K902472
- Device name
- MORSE DT MANIFOLD
- Applicant
- North American Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-04
- Decision date
- 1990-08-23
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- 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 Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood recall (Z-2141-2026) | Medline Industries, LP | 2026-05-08 |
| Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood recall (Z-2142-2026) | Medline Industries, LP | 2026-05-08 |