DA-16 AND DA-24 SHUNT ADAPTERS
FDA 510(k) clearance K893478 · decided 1989-06-08
Clearance details
- K-number
- K893478
- Device name
- DA-16 AND DA-24 SHUNT ADAPTERS
- Applicant
- Akcess Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-04
- Decision date
- 1989-06-08
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FKN
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New Brunswick, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Akcess Medical Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 (K892667) | Akcess Medical Products, Inc. | 1989-05-04 |
| SHUNT ADAPTER (K813428) | Quinton, Inc. | 1981-12-31 |
| A-V SHUNT EXTENSION (K771425) | Quinton, Inc. | 1978-01-03 |
Recalls involving this device
No recalls on record reference this clearance.