Millar Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 18
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Millar Instruments, Inc. makes
Millar Instruments, Inc. manufactures pressure transducers and related monitoring devices for cardiovascular applications, including Mikro-Tip catheter pressure transducers, angiographic catheters, Doppler catheters, and pulsed Doppler velocimeters. The company also produces transducer-monitor interfacing units, pressure control units such as the PCU-2000, and specialized catheters like the Cathia-Cath and phonotrans catheters.
The devices manufactured by Millar Instruments, Inc. are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 18 devicesFDA recalls
FDA recall records list 3 recalls initiated by Millar Instruments, Inc., the earliest on 2005-01-14 and the most recent on 2011-03-08. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 8 Mar 2011 Z-1725-2011 Unclassified (pre-2012) Terminated Possibility of epoxy debris particles inside the catheter lumen.
2010
- 14 Oct 2010 Z-0401-2011 Unclassified (pre-2012) Terminated The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.
2005
- 14 Jan 2005 Z-0635-05 Unclassified (pre-2012) Terminated Wire braiding protruding from the catheter.
Frequently asked questions
How many devices does Millar Instruments, Inc. have in the registry?
The registry currently lists 18 devices for Millar Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Millar Instruments, Inc.'s devices?
Among its 18 most recently registered devices, Millar Instruments, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Millar Instruments, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Millar Instruments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Millar Instruments, Inc.?
FDA recall records list 3 recalls initiated by Millar Instruments, Inc., the most recent initiated on 8 Mar 2011. 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 Millar Instruments, Inc. in the registry?
The most recently registered devices listed for Millar Instruments, Inc. include TRANSDUCER-MONITOR INTERFACING, CARDIA-CATH, MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 and MIKRO-TIP CATH. PRESSURE TRANSDUCER.