CENTRAL VENOUS ACCESS CATHETER CVAC
FDA 510(k) clearance K832396 · decided 1983-08-31
Clearance details
- K-number
- K832396
- Device name
- CENTRAL VENOUS ACCESS CATHETER CVAC
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-20
- Decision date
- 1983-08-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- DOY
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| USCI ILLUMEN-8 8F PTCA GUIDING CATHETER (K910154) | C.R. Bard, Inc. | 1991-04-09 |
| WALRUS PERCUTANEOUS INTRODUCER SET (K831239) | Medical Parameters, Inc. | 1983-05-25 |
| VASCULAR CATHETER (K831191) | Medrad, Inc. | 1983-05-09 |
| CONNECTOR TUBE (K831188) | Medrad, Inc. | 1983-05-09 |
Recalls involving this device
No recalls on record reference this clearance.