Flowcardia, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 11 devicesFDA recalls
2009
- 9 Jan 2009 Z-0938-2011 Unclassified (pre-2012) Terminated Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.
Frequently asked questions
How many devices does Flowcardia, Inc. have in the registry?
The registry currently lists 11 devices for Flowcardia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flowcardia, Inc.'s devices?
Among its 11 most recently registered devices, Flowcardia, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Flowcardia, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Flowcardia, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Flowcardia, Inc.?
FDA recall records list 1 recall initiated by Flowcardia, Inc., the most recent initiated on 2009-01-09. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Flowcardia, Inc. in the registry?
The most recently registered devices listed for Flowcardia, Inc. include THE CROSSER 14 OTW CATHETER, MODEL CRU014, THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02, MICROSHEATH XL CATHETERS and VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO.