Ptca Balloon Catheters & Access.
FDA 510(k) K834433 · Advanced Cardiovascular Systems, Inc.
510(k) numberK834433
Submission
- Device name
- Ptca Balloon Catheters & Access.
- Applicant
- Advanced Cardiovascular Systems, Inc.
Walker, MI, US - Received
- December 7, 1983
- Decision date
- April 24, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Ptca Balloon Catheters & Access. cleared by the FDA?
Ptca Balloon Catheters & Access. (K834433) received a 510(k) decision of Substantially Equivalent on April 24, 1984, 139 days after the submission was received.