Fasguide Catheter
FDA 510(k) K935597 · Target Therapeutics
510(k) numberK935597
Submission
- Device name
- Fasguide Catheter
- Applicant
- Target Therapeutics
Freemont, CA, US - Received
- November 19, 1993
- Decision date
- October 18, 1994
- 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 Fasguide Catheter cleared by the FDA?
Fasguide Catheter (K935597) received a 510(k) decision of Substantially Equivalent on October 18, 1994, 333 days after the submission was received.
What is the product code of K935597?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.