Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F
FDA 510(k) K961280 · Scimed Life Systems, Inc.
510(k) numberK961280
Submission
- Device name
- Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F
- Applicant
- Scimed Life Systems, Inc.
Maple Grove, MN, US - Received
- April 3, 1996
- Decision date
- May 15, 1996
- 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 Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F cleared by the FDA?
Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F (K961280) received a 510(k) decision of Substantially Equivalent on May 15, 1996, 42 days after the submission was received.
What is the product code of K961280?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.