MENSINK-GOOSEN CATHETER
FDA 510(k) clearance K844889 · decided 1985-03-18
Clearance details
- K-number
- K844889
- Device name
- MENSINK-GOOSEN CATHETER
- Applicant
- Goosen Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-17
- Decision date
- 1985-03-18
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- GBP
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Goldenrod, FL, 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 |
|---|---|---|
| MULTILUMEN INTRAVENOUS INFUSION CATHETER (K821220) | Clincal Instruments Corp. | 1982-07-09 |
| CATHETER, MULTIPLE LUMEN (K820446) | Dlp, Inc. | 1982-03-11 |
Recalls involving this device
No recalls on record reference this clearance.