PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F— 510(k) K960715

Name: FDA 510(k) clearance K960715
Creator: U.S. Food and Drug Administration
Published: 1996-09-09

Substantially Equivalent

Ideas For Medicine, Inc.

FDA 510(k) clearance K960715 for PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F, Substantially Equivalent on 1996-09-09. Applicant: Ideas For Medicine, Inc.. Device class: 2.

Clearance details

Applicant: Ideas For Medicine, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 1996-02-21
Decision date: 1996-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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K961883 — VERSA-CATH ARTERIAL CATHETER1997-01-13
K962751 — IDEAS' DUAL PORT1996-09-30
K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE1996-09-19
K960422 — PRUITT SAFETY OCCLUSION CATHETER1996-08-07
K954713 — DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)1996-07-24

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.