FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMOTHERAPY INFUSION CATHETER
K Number: K822096
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
13
Applicant Total
13
Review Days
270
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Basic Information
- Device Name
- CHEMOTHERAPY INFUSION CATHETER
- K Number
- K822096
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Heyer Schulte
- Date Received
- July 16, 1982
- Decision Date
- April 12, 1983
- Product Code
- JCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JCY | Catheter, Infusion | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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SILICONE ELASTOMER INFUSION CATHETER
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Other Clearances by American Heyer Schulte
| K Number | Device Name | ||
|---|---|---|---|
| K840172 | VENTRAL WALL DEFECT REDUCT SILO | Jun 27, 1984 | Substantially Equivalent |
| K834593 | ONE-PIECE SHUNT | Apr 3, 1984 | Substantially Equivalent |
| K833502 | RADOVAN SUBCUTANEOUS TISSUE EXPANDER | Feb 3, 1984 | Substantially Equivalent |
| K833698 | AMER. V. MUELLER SURG. STAPLES ILA | Jan 25, 1984 | Substantially Equivalent |
| K833704 | AMER. V. MUELLER SURGICALSTAPLES-CARTR | Dec 29, 1983 | Substantially Equivalent |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | Sep 29, 1983 | Substantially Equivalent |
| K823790 | VENTRICULAR ACCESS SYSTEM | Apr 28, 1983 | Substantially Equivalent |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | Aug 16, 1982 | Substantially Equivalent |
| K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | Feb 18, 1982 | Substantially Equivalent |
| K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | Jun 26, 1981 | Substantially Equivalent |