The following data is part of a premarket notification filed by Texas Medical Technologies, Inc. with the FDA for Txm Support Catheter.
Device ID | K170914 |
510k Number | K170914 |
Device Name: | TXM Support Catheter |
Classification | Catheter, Percutaneous |
Applicant | Texas Medical Technologies, Inc. 2118 Wilshire Blvd. #682 Santa Monica, CA 90403 |
Contact | Ed Anderson |
Correspondent | E.j. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-28 |
Decision Date | 2017-11-21 |
Summary: | summary |