FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEMAITRE OCCLUSION CATHETER
K Number: K992942
·
Decision Apr 13, 2000
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
14
Review Days
226
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Basic Information
- Device Name
- LEMAITRE OCCLUSION CATHETER
- K Number
- K992942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vascutech, Inc.
- Date Received
- August 31, 1999
- Decision Date
- April 13, 2000
- Product Code
- MJN
- 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 |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Vascutech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001621 | DARDIK CAROTID SHUNT | Dec 6, 2000 | Substantially Equivalent |
| K992933 | LEMAITRE IRRIGATION CATHETER | Mar 8, 2000 | Substantially Equivalent |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | Mar 1, 2000 | Substantially Equivalent |
| K992940 | LEMAITRE BALLOON CATHETER WITH IRRIGATION | Feb 22, 2000 | Substantially Equivalent |
| K992941 | LEMAITRE BILIARY CATHETER | Jan 12, 2000 | Substantially Equivalent |
| K992368 | LEMAITRE EMBOLECTOMY CATHETER | Dec 9, 1999 | Substantially Equivalent |
| K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | Feb 12, 1999 | Substantially Equivalent |
| K946352 | LEMAITRE VALVULOTOME II | Jun 21, 1995 | Substantially Equivalent |
| K932009 | THE SAMUELS RETROGRAD VALVULOTOME | Sep 21, 1993 | Substantially Equivalent |
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE | Jul 22, 1993 | Substantially Equivalent |