FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
K Number: K926217
·
Decision Jul 13, 1993
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
143
Review Days
215
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Basic Information
- Device Name
- TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
- K Number
- K926217
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Terumo Medical Corp.
- Date Received
- December 10, 1992
- Decision Date
- July 13, 1993
- Product Code
- GBZ
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBZ), ordered by most recent decision date.
PRE-VIEW CHOLANGIOGRAPHY CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANGIOLAPCATH CHOLANGIOGRAPHY KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Terumo Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111556 | GLIDECROSS SUPPORT CATHETER | Jul 29, 2011 | Substantially Equivalent |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 | Substantially Equivalent |
| K102008 | GLIDESHEATH | Jul 21, 2010 | Substantially Equivalent |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 | Substantially Equivalent |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Apr 15, 2009 | Substantially Equivalent |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Feb 6, 2009 | Substantially Equivalent |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Oct 29, 2008 | Substantially Equivalent |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Sep 24, 2008 | Substantially Equivalent |