FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
OPTI-PLAST ANGIOPLASTY CATHETER
K Number: K941706
·
Decision Oct 18, 1994
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
27
Review Days
195
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Basic Information
- Device Name
- OPTI-PLAST ANGIOPLASTY CATHETER
- K Number
- K941706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vas-Cath, Inc.
- Date Received
- April 6, 1994
- Decision Date
- October 18, 1994
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Vas-Cath, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973013 | OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER | Jun 19, 1998 | Substantially Equivalent |
| K965178 | NIAGARA DUAL LUMEN CATHETER | Aug 19, 1997 | Substantially Equivalent |
| K964881 | ULTRAVERSE PTA CATHETER | May 28, 1997 | Substantially Equivalent |
| K970725 | OPTI-PLAST XL 5.5 F PTA CATHETER | May 9, 1997 | Substantially Equivalent |
| K925485 | VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER | Mar 10, 1994 | Substantially Equivalent |
| K933483 | OPTI-PLAST 5F PTA CATHETERS | Sep 24, 1993 | Substantially Equivalent |
| K914210 | VAS-CATH DUALATOR(TM) VESSEL DILATOR | Jul 1, 1993 | Substantially Equivalent |
| K914162 | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS | Jul 1, 1993 | Substantially Equivalent |
| K914976 | OPTI-PLAST 5F PTA CATHETERS, MODIFICATION | Jan 27, 1992 | Substantially Equivalent |
| K914500 | OPTI-PLAST 5F PTA CATHETERS, MODIFICATION | Dec 31, 1991 | Substantially Equivalent |