FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
K Number: K892926
·
Decision Dec 5, 1989
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
27
Review Days
228
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Basic Information
- Device Name
- DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
- K Number
- K892926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Vas-Cath, Inc.
- Date Received
- April 21, 1989
- Decision Date
- December 5, 1989
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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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 |
| 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 |
| 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 |