Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter
FDA 510(k) K950026 · Medtronics Interventional Vascular
510(k) numberK950026
Submission
- Device name
- Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter
- Applicant
- Medtronics Interventional Vascular
Danvers, MA, US - Received
- January 4, 1995
- Decision date
- April 5, 1995
- 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 Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter cleared by the FDA?
Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter (K950026) received a 510(k) decision of Substantially Equivalent on April 5, 1995, 91 days after the submission was received.
What is the product code of K950026?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.