FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORDIS TUNNELER
K Number: K932273
·
Decision Aug 23, 1993
Classifications
1
FEI Numbers
21
Registration Numbers
22
Same Product Code
12
Applicant Total
315
Review Days
102
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Basic Information
- Device Name
- CORDIS TUNNELER
- K Number
- K932273
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4545
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cordis Corp.
- Date Received
- May 13, 1993
- Decision Date
- August 23, 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
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FDA Class 1
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Other Clearances by Cordis Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130981 | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM | Mar 12, 2014 | Unknown |
| K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | May 4, 2012 | Substantially Equivalent |
| K101651 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Jul 9, 2010 | Substantially Equivalent |
| K082143 | MICRO GUIDE CATHETER XP | Aug 25, 2008 | Substantially Equivalent |
| K062798 | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB | Feb 6, 2008 | Unknown |
| K060877 | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX | Apr 27, 2006 | Unknown |
| K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER | Apr 1, 2005 | Substantially Equivalent |
| K040592 | CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE | Dec 17, 2004 | Substantially Equivalent |
| K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Nov 8, 2004 | Unknown |
| K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | Dec 22, 2003 | Unknown |