FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL VENTRICULAR DRAINAGE SYS.
K Number: K820247
·
Decision Feb 18, 1982
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
13
Review Days
20
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Basic Information
- Device Name
- EXTERNAL VENTRICULAR DRAINAGE SYS.
- K Number
- K820247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- American Heyer Schulte
- Date Received
- January 29, 1982
- Decision Date
- February 18, 1982
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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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 |
| K822096 | CHEMOTHERAPY INFUSION CATHETER | Apr 12, 1983 | Substantially Equivalent |
| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | Aug 16, 1982 | Substantially Equivalent |
| K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | Jun 26, 1981 | Substantially Equivalent |