DC-4 SHUNT INFUSION T
FDA 510(k) clearance K891754 · decided 1989-04-07
Clearance details
- K-number
- K891754
- Device name
- DC-4 SHUNT INFUSION T
- Applicant
- Akcess Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-23
- Decision date
- 1989-04-07
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FKB
- Device class
- 2
- Regulation number
- 876.5820
- 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 |
|---|---|---|
| PEDIATRIC INFUSION T (K771426) | Quinton, Inc. | 1977-12-20 |
Recalls involving this device
No recalls on record reference this clearance.