Enpath Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Enpath Medical, Inc. makes
Enpath Medical, Inc. manufactures peelable introducers, including the VIAPEEL peelable introducer, PTFE interlock peelable introducers, and the VIASEAL valved peelable introducer (model 10866-XXX). The company also produces a stiffer coaxial micro-introducer kit and a steerable sheath.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. Enpath Medical, Inc. is based in the United States.
Catalogue
Viapeel Peelable Introducer Ref K072248
Regimes: 510(k) Registry: 510(k)Ptfe Interlock Peelable Introducers Ref K081394
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Stiffer Coaxial Micro-Introducer Kit Ref K071574
Regimes: 510(k) Registry: 510(k)Enpath Medical Steerable Sheath Ref K061119
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Enpath Medical, Inc., the earliest on 2004-02-26 and the most recent on 2006-07-18. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 18 Jul 2006 Z-0120-2007 Unclassified (pre-2012) Terminated Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
- 18 Jul 2006 Z-0121-2007 Unclassified (pre-2012) Terminated The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
- 27 Jun 2006 Z-0118-2007 Unclassified (pre-2012) Terminated Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.
2005
- 31 Aug 2005 Z-1573-05 Unclassified (pre-2012) Terminated Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.
2004
- 26 Feb 2004 Z-0711-04 Unclassified (pre-2012) Terminated The product is labeled as sterile product but had not been sterilized.
Frequently asked questions
How many devices does Enpath Medical, Inc. have in the registry?
The registry currently lists 5 devices for Enpath Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enpath Medical, Inc.'s devices?
Among its 5 most recently registered devices, Enpath Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Enpath Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Enpath Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Enpath Medical, Inc.?
FDA recall records list 5 recalls initiated by Enpath Medical, Inc., the most recent initiated on 2006-07-18. 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 Enpath Medical, Inc. in the registry?
The most recently registered devices listed for Enpath Medical, Inc. include VIAPEEL PEELABLE INTRODUCER, PTFE INTERLOCK PEELABLE INTRODUCERS, ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX and STIFFER COAXIAL MICRO-INTRODUCER KIT.