TXM Support Catheter
FDA 510(k) K170914 · Texasmedical Technologies, Inc.
510(k) numberK170914
Submission
- Device name
- TXM Support Catheter
- Applicant
- Texasmedical Technologies, Inc.
Santa Monica, CA, US - Received
- March 28, 2017
- Decision date
- November 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was TXM Support Catheter cleared by the FDA?
TXM Support Catheter (K170914) received a 510(k) decision of Substantially Equivalent on November 21, 2017, 238 days after the submission was received.
What is the product code of K170914?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.