FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE LEMAITRE GLOW 'N TELL TAPE
K Number: K932184
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
14
Review Days
78
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Basic Information
- Device Name
- STERILE LEMAITRE GLOW 'N TELL TAPE
- K Number
- K932184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vascutech, Inc.
- Date Received
- May 5, 1993
- Decision Date
- July 22, 1993
- Product Code
- KFX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFX), ordered by most recent decision date.
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ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
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Other Clearances by Vascutech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001621 | DARDIK CAROTID SHUNT | Dec 6, 2000 | Substantially Equivalent |
| K992942 | LEMAITRE OCCLUSION CATHETER | Apr 13, 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 |