FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VAS-CATH DUALATOR(TM) VESSEL DILATOR
K Number: K914210
·
Decision Jul 1, 1993
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
27
Review Days
651
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Basic Information
- Device Name
- VAS-CATH DUALATOR(TM) VESSEL DILATOR
- K Number
- K914210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vas-Cath, Inc.
- Date Received
- September 19, 1991
- Decision Date
- July 1, 1993
- Product Code
- FKA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKA | Dilator, Vessel | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKA), ordered by most recent decision date.
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VESSEL DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K941706 | OPTI-PLAST ANGIOPLASTY CATHETER | Oct 18, 1994 | 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 |
| 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 |