Catheter Research, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Catheter Research, Inc. makes
Catheter Research, Inc. manufactures single-use and reusable medical devices for diagnostic and procedural applications, including uterine injectors and manipulators for reproductive health procedures, disposable esophageal stethoscopes for clinical auscultation, and gas sampling lines and airway connectors for respiratory monitoring. Their portfolio also includes H/S catheter sets and a dedicated catheter for hysterosalpingography (HSG) and saline infusion sonography (SIS).
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Intrauterine Insemination (Iui) Catheter Ref K120154
Regimes: 510(k) Registry: 510(k)Uterine Injector Ref K020292
Regimes: 510(k) Registry: 510(k)Disposable Esophageal Stethoscope Ref K973839
Regimes: 510(k) Registry: 510(k)Disposable Gas Sampling Lines Ref K946044
Regimes: 510(k) Registry: 510(k)Uterine Manipulator/Injector Ref K974357
Regimes: 510(k) Registry: 510(k)H/S Catheter Set Ref K032835
Regimes: 510(k) Registry: 510(k)The Advance Catheter For Hsg And Sis Ref K123258
Regimes: 510(k) Registry: 510(k)Disposable Airway Connectors For Gas Sampling Ref K951345
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Catheter Research, Inc., the earliest on 2006-04-24 and the most recent on 2015-04-07. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 7 Apr 2015 Z-1481-2015 Class II Terminated HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
2006
- 24 Apr 2006 Z-1077-06 Unclassified (pre-2012) Terminated The uterine stop component was not included with the device.
Frequently asked questions
How many devices does Catheter Research, Inc. have in the registry?
The registry currently lists 8 devices for Catheter Research, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Catheter Research, Inc.'s devices?
Among its 8 most recently registered devices, Catheter Research, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Catheter Research, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Catheter Research, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Catheter Research, Inc.?
FDA recall records list 2 recalls initiated by Catheter Research, Inc., the most recent initiated on 7 Apr 2015. 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 Catheter Research, Inc. in the registry?
The most recently registered devices listed for Catheter Research, Inc. include INTRAUTERINE INSEMINATION (IUI) CATHETER, UTERINE INJECTOR, DISPOSABLE ESOPHAGEAL STETHOSCOPE and DISPOSABLE GAS SAMPLING LINES.