Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)
FDA 510(k) K962495 · Advanced Cardiovascular Systems, Inc.
510(k) numberK962495
Submission
- Device name
- Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)
- Applicant
- Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US - Received
- June 26, 1996
- Decision date
- September 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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Questions and answers
When was Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve) cleared by the FDA?
Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve) (K962495) received a 510(k) decision of Substantially Equivalent on September 12, 1996, 78 days after the submission was received.
What is the product code of K962495?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.