REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING— 510(k) K935184

Substantially Equivalent

St. Jude Medical, Inc.

FDA 510(k) clearance K935184 for REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING, Substantially Equivalent on 1995-02-10. Applicant: St. Jude Medical, Inc..

Clearance details

Applicant: St. Jude Medical, Inc.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 1993-10-26
Decision date: 1995-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

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Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.