SHUNT CONNECTORS
FDA 510(k) clearance K893679 · decided 1989-07-24
Clearance details
- K-number
- K893679
- Device name
- SHUNT CONNECTORS
- Applicant
- Akcess Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-16
- Decision date
- 1989-07-24
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- FJQ
- Device class
- 1
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PATIENT BY-PASS (K771422) | Quinton, Inc. | 1978-01-03 |
| DISP. TEFLON CONNHCTOR (K771429) | Quinton, Inc. | 1977-12-22 |
Recalls involving this device
No recalls on record reference this clearance.