9 French Large Lumen Triguide Plus Guiding Catheter
FDA 510(k) K934988 · Scimed Life Systems, Inc.
510(k) numberK934988
Submission
- Device name
- 9 French Large Lumen Triguide Plus Guiding Catheter
- Applicant
- Scimed Life Systems, Inc.
Plymouth, MN, US - Received
- October 18, 1993
- Decision date
- January 14, 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 9 French Large Lumen Triguide Plus Guiding Catheter cleared by the FDA?
9 French Large Lumen Triguide Plus Guiding Catheter (K934988) received a 510(k) decision of Substantially Equivalent on January 14, 1994, 88 days after the submission was received.
What is the product code of K934988?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.