Guiding Catheter
FDA 510(k) K153703 · Texasmedical Technologies, Inc.
510(k) numberK153703
Submission
- Device name
- Guiding Catheter
- Applicant
- Texasmedical Technologies, Inc.
El Paso, TN, US - Received
- December 23, 2015
- Decision date
- May 12, 2016
- 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 Guiding Catheter cleared by the FDA?
Guiding Catheter (K153703) received a 510(k) decision of Substantially Equivalent on May 12, 2016, 141 days after the submission was received.
What is the product code of K153703?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.