Foxhollow Technologies, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Foxhollow Technologies, Inc. makes
Foxhollow Technologies, Inc. manufactures the SilverHawk Peripheral Plaque Excision System, a device designed for the removal of atherosclerotic plaque from peripheral arteries. The system includes a modification for the P4028/FG08300 model, intended for use in endovascular procedures.
The SilverHawk Peripheral Plaque Excision System is classified as a Class II medical device in the US. It is listed under the FDA’s 510(k) pathway, reflecting its regulatory authorisation status. The company is based in the United States.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 Ref K024243
510(k) 510(k)Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 02406, 04706, 04300 Ref K043553
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Silverhawk Peripheral Plaque Excision System Ref K061188
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Foxhollow Technologies, Inc., initiated on 2004-06-17. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 17 Jun 2004 Z-1091-04 Unclassified (pre-2012) Terminated Devices for which sterility may be compromised.
Full distribution text
- 17 Jun 2004 Z-1091-04 Unclassified (pre-2012) Terminated Devices for which sterility may be compromised.
Frequently asked questions
How many devices does Foxhollow Technologies, Inc. have in the registry?
The registry currently lists 7 devices for Foxhollow Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Foxhollow Technologies, Inc.'s devices?
Among its 7 most recently registered devices, Foxhollow Technologies, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Foxhollow Technologies, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Foxhollow Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Foxhollow Technologies, Inc.?
FDA recall records list 1 recall initiated by Foxhollow Technologies, Inc., the most recent initiated on 2004-06-17. 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 Foxhollow Technologies, Inc. in the registry?
The most recently registered devices listed for Foxhollow Technologies, Inc. include THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910, MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,, REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 and SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 02406, 04706, 04300.