Company ยท US
Sentreheart, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2015. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2015 | K153096 | LARIAT RS Suture Delivery Device Sentreheart, Inc. | GAT |
| Sep 12, 2014 | K142241 | LARIAT sulture Delivery Device Sentreheart, Inc. | GAT |
| May 6, 2009 | K090385 | LARIAT II SUTURE DELIVERY DEVICE Sentreheart, Inc. | GAT |
| Aug 11, 2008 | K080364 | FINDRWIRZ GUIDE WIRE SYSTEM Sentreheart, Inc. | DQX |
| Feb 8, 2008 | K070126 | OCCLUSION BALLOON CATHETER Sentreheart, Inc. | DQY |
| Jun 2, 2006 | K060721 | LARIAT LOOP APPLICATOR Sentreheart | GAT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2016 | SentreHeart Inc FindrWIRZ Guidewire System Catalog# 40-05
Cardiology:
The system is intended for use in the cardiovascular system for
introduction and positioning of over the-wire catheters and therapeutic devices d Terminated |
DQX | K080364 |