STERILE LEMAITRE GLOW 'N TELL TAPE
FDA 510(k) clearance K932184 · decided 1993-07-22
Clearance details
- K-number
- K932184
- Device name
- STERILE LEMAITRE GLOW 'N TELL TAPE
- Applicant
- Vascutech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-05
- Decision date
- 1993-07-22
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KFX
- Device class
- 2
- Regulation number
- 890.3500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- North Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Inte recall (Z-1054-2013) | LeMaitre Vascular, Inc. | 2013-04-04 |
| Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). I recall (Z-1055-2013) | LeMaitre Vascular, Inc. | 2013-04-04 |
| LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips Catalog Number: 1102-2 recall (Z-0433-2011) | Lemaitre Vascular, Inc. | 2010-11-22 |
| LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips Catalog Number: 1102- recall (Z-0434-2011) | Lemaitre Vascular, Inc. | 2010-11-22 |
| LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips Catalog Number: 110 recall (Z-0435-2011) | Lemaitre Vascular, Inc. | 2010-11-22 |
| LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips Catalog Number: 1108- recall (Z-0436-2011) | Lemaitre Vascular, Inc. | 2010-11-22 |