CATHETER, MULTIPLE LUMEN
FDA 510(k) clearance K820446 · decided 1982-03-11
Clearance details
- K-number
- K820446
- Device name
- CATHETER, MULTIPLE LUMEN
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-18
- Decision date
- 1982-03-11
- Days to decision
- 21 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
- Walker, MI, 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 |
|---|---|---|
| MENSINK-GOOSEN CATHETER (K844889) | Goosen Enterprises, Inc. | 1985-03-18 |
| MULTILUMEN INTRAVENOUS INFUSION CATHETER (K821220) | Clincal Instruments Corp. | 1982-07-09 |
Recalls involving this device
No recalls on record reference this clearance.