Company ยท US
Catheter Research, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2013. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2013 | K123258 | THE ADVANCE CATHETER FOR HSG AND SIS Catheter Research, Inc. | LKF |
| Mar 21, 2012 | K120154 | INTRAUTERINE INSEMINATION (IUI) CATHETER Catheter Research, Inc. | MQF |
| Dec 11, 2003 | K032835 | H/S CATHETER SET Catheter Research, Inc. | LKF |
| Apr 17, 2002 | K020292 | UTERINE INJECTOR Catheter Research, Inc. | LKF |
| Mar 19, 1998 | K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE Catheter Research, Inc. | BZT |
| Feb 2, 1998 | K974357 | UTERINE MANIPULATOR/INJECTOR Catheter Research, Inc. | LKF |
| Apr 14, 1995 | K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING Catheter Research, Inc. | BZA |
| Dec 27, 1994 | K946044 | DISPOSABLE GAS SAMPLING LINES Catheter Research, Inc. | CCK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2015 | Catheter Research, Inc HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use. Terminated |
HGS | K032835 |
| Jun 1, 2006 | Catheter Research, Inc Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid Terminated |
LKF | K020292 |