Novoste Corp.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Novoste Corp. makes
Novoste Corp. manufactures a range of catheters, including guiding catheters, angiographic catheters, and blood containment devices. Their portfolio includes standard and modified angiographic catheters sized in French measurements (4, 4.2, 5, and 6 Fr) as well as a pulse-plus blood containment device designed for procedural safety.
These devices are classified under Class II by the FDA and are listed via the 510(k) pathway. The company operates within the United States regulatory framework, adhering to FDA requirements for medical device authorisation.
Catalogue
Novoste Guiding Catheter Ref K911527
Regimes: 510(k) Registry: 510(k)Novoste 4, 4.2, 5 And 6 French Catheters Ref K875127
Regimes: 510(k) Registry: 510(k)Modified Novoste Angiographic Catheter Ref K900460
Regimes: 510(k) Registry: 510(k)Novoste Pulse Plus Blood Containment Device Ref K942977
Regimes: 510(k) Registry: 510(k)Modified Angiographic Catheter Ref K896690
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Novoste Corp., initiated on 2002-01-25. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 25 Jan 2002 Z-0462-03 Unclassified (pre-2012) Terminated Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
Full distribution text
- 25 Jan 2002 Z-0462-03 Unclassified (pre-2012) Terminated Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
Frequently asked questions
How many devices does Novoste Corp. have in the registry?
The registry currently lists 5 devices for Novoste Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novoste Corp.'s devices?
Among its 5 most recently registered devices, Novoste Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Novoste Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Novoste Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Novoste Corp.?
FDA recall records list 1 recall initiated by Novoste Corp., the most recent initiated on 25 Jan 2002. 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 Novoste Corp. in the registry?
The most recently registered devices listed for Novoste Corp. include NOVOSTE GUIDING CATHETER, NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS, MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER and NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE.