510(k) K932184 ยท KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External
STERILE LEMAITRE GLOW 'N TELL TAPE
| Applicant | Vascutech, Inc., North Andover MA, US |
| Decision | Substantially Equivalent, Jul 22, 1993 |
| Received | May 5, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2013 | LeMaitre Vascular, Inc. LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips).
Intended to be placed on the skin to assist during imaging procedures. Terminated |
KFX | None listed |
| Apr 4, 2013 | LeMaitre Vascular, Inc. Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).
Intended to be placed on the skin to assist during imaging procedures. Terminated |
KFX | None listed |
| Nov 22, 2010 | Lemaitre Vascular, Inc. LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips
Catalog Number: 1102-20
Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal f Terminated |
FTY | None listed |
| Nov 22, 2010 | Lemaitre Vascular, Inc. LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips
Catalog Number: 1102-00
Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal Terminated |
FTY | None listed |
| Nov 22, 2010 | Lemaitre Vascular, Inc. LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100 strips
Catalog Number: 1100-00
Intended to be placed on the patient's skin to assist during imaging procedures by serving as an interna Terminated |
FTY | None listed |
| Nov 22, 2010 | Lemaitre Vascular, Inc. LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips
Catalog Number: 1108-20
Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal Terminated |
FTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.