TAMARI-KAPLITT— 510(k) K760695

Name: FDA 510(k) clearance K760695
Creator: U.S. Food and Drug Administration
Published: 1976-10-06

Substantially Equivalent

Yehuda Tamari

FDA 510(k) clearance K760695 for TAMARI-KAPLITT, Substantially Equivalent on 1976-10-06. Applicant: Yehuda Tamari. Device class: 2.

Clearance details

Applicant: Yehuda Tamari
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 1976-09-20
Decision date: 1976-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

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.