FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
V/P AND L/P CATHETER PASSERS
K Number: K934391
·
Decision Nov 19, 1993
Classifications
1
FEI Numbers
21
Registration Numbers
22
Same Product Code
12
Applicant Total
56
Review Days
71
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Basic Information
- Device Name
- V/P AND L/P CATHETER PASSERS
- K Number
- K934391
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4545
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, Inc.
- Date Received
- September 9, 1993
- Decision Date
- November 19, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYK), ordered by most recent decision date.
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PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
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HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
FDA 510(k)
FDA Class 1
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Other Clearances by Radionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | Apr 4, 2003 | Substantially Equivalent |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | Oct 23, 2000 | Substantially Equivalent |
| K002773 | NEUROMAP WITH NEURO 100 | Oct 23, 2000 | Substantially Equivalent |
| K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | Aug 4, 2000 | Substantially Equivalent |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | Jul 26, 2000 | Substantially Equivalent |
| K001700 | XPLAN 2.1 | Jun 28, 2000 | Substantially Equivalent |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | May 17, 2000 | Substantially Equivalent |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | Mar 20, 2000 | Substantially Equivalent |
| K993594 | CONFORMAX MMLC VR1 | Dec 15, 1999 | Substantially Equivalent |
| K991399 | RADIONICS MICROELECTRODE KIT | Sep 21, 1999 | Substantially Equivalent |