PEDIATRIC INFUSION T
FDA 510(k) clearance K771426 · decided 1977-12-20
Clearance details
- K-number
- K771426
- Device name
- PEDIATRIC INFUSION T
- Applicant
- Quinton, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-01
- Decision date
- 1977-12-20
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- FKB
- Device class
- 2
- Regulation number
- 876.5820
- 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 |
|---|---|---|
| DC-4 SHUNT INFUSION T (K891754) | Akcess Medical Products, Inc. | 1989-04-07 |
Recalls involving this device
No recalls on record reference this clearance.