CHEMOTHERAPY INFUSION CATHETER
FDA 510(k) clearance K822096 · decided 1983-04-12
Clearance details
- K-number
- K822096
- Device name
- CHEMOTHERAPY INFUSION CATHETER
- Applicant
- American Heyer Schulte
- Decision
- Substantially Equivalent
- Date received
- 1982-07-16
- Decision date
- 1983-04-12
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- JCY
- 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 |
|---|---|---|
| VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (K863982) | Vas-Cath of Canada , Ltd. | 1986-10-24 |
| SILICONE SUMP DRAIN 20 & 40 FRENCH (K840324) | Superior Plastic Products Corp. | 1984-04-25 |
| TRIPLE LUMEN INFUSIONCATHETERS- (K834615) | Medical Components, Inc. | 1984-02-14 |
| SILCATH CENTRAL CATHETER TRAY W/18 GA (K831453) | Argon Medical Corp. | 1983-07-28 |
| SILCATH CENTRAL CATHETER TRAY SIZE- (K831451) | Argon Medical Corp. | 1983-06-08 |
| SILICONE ELASTOMER INFUSION CATHETER (K813606) | Quest Medical, Inc. | 1982-01-18 |
| JELCO & KVO CATHETER PLACEMENT UNIT (K791372) | Jelco Laboratories | 1979-09-12 |
| CATHETER, CEBTRAL VENOUS, 2N1501 (K771861) | Travenol Laboratories, S.A. | 1977-11-28 |
| CATHETER, INTRAVASCULAR (ARGYLE IV SK) (K760760) | Sherwood Medical Industries | 1976-12-09 |
| CATHETER, VEIN (BRAUNULA) (K760391) | B. Braun Instruments | 1976-11-02 |
| INTRAVENOUS TRANSFER SET (INTRAFIX) (K760380) | B. Braun Instruments | 1976-11-02 |
| BLOOD TRANSFUSION SET (SANGOFIX) (K760381) | B. Braun Instruments | 1976-11-02 |
Recalls involving this device
No recalls on record reference this clearance.