INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)— 510(k) K962495

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K962495 for INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE), Substantially Equivalent on 1996-09-12. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1996-06-26
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.