Lumend, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Lumend, Inc. makes
Lumend, Inc. manufactures coronary and peripheral catheter systems, including the Outback Catheter and Lumend FrontRunner CTO (Chronic Total Occlusion) Catheter series. These devices are designed for guiding and navigating through complex vascular blockages, with some models offering modifications for enhanced performance. The portfolio also includes percutaneous catheters and accessories tailored for interventional cardiology procedures.
The company’s catheter products fall under FDA Class II devices and are authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. Lumend, Inc. is based in the United States.
Catalogue
Search and filter all 11 devicesFDA recalls
FDA recall records list 1 recall initiated by Lumend, Inc., initiated on 2004-05-18. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 18 May 2004 Z-0995-04 Unclassified (pre-2012) Terminated Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
Frequently asked questions
How many devices does Lumend, Inc. have in the registry?
The registry currently lists 11 devices for Lumend, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumend, Inc.'s devices?
Among its 11 most recently registered devices, Lumend, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Lumend, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Lumend, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lumend, Inc.?
FDA recall records list 1 recall initiated by Lumend, Inc., the most recent initiated on 18 May 2004. 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 Lumend, Inc. in the registry?
The most recently registered devices listed for Lumend, Inc. include MODIFICATION TO OUTBACK CATHETER, MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER, LUMEND FRONTRUNNER CTO CORONARY CATHETER and LUMEND PERCUTANEOUS CATHETER.