SHUNT ADAPTER
FDA 510(k) clearance K813428 · decided 1981-12-31
Clearance details
- K-number
- K813428
- Device name
- SHUNT ADAPTER
- Applicant
- Quinton, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-08
- Decision date
- 1981-12-31
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- FKN
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DA-16 AND DA-24 SHUNT ADAPTERS (K893478) | Akcess Medical Products, Inc. | 1989-06-08 |
| SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 (K892667) | Akcess Medical Products, Inc. | 1989-05-04 |
| A-V SHUNT EXTENSION (K771425) | Quinton, Inc. | 1978-01-03 |
Recalls involving this device
No recalls on record reference this clearance.