FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K Number: K883607
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
22
Same Product Code
12
Applicant Total
152
Review Days
38
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Basic Information
- Device Name
- PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
- K Number
- K883607
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4545
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- August 23, 1988
- Decision Date
- September 30, 1988
- Product Code
- GYK
- 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 |
|---|---|---|---|
| GYK | Instrument, Shunt System Implantation | FDA class 1 | Neurology |
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HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
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