BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER— 510(k) K051513

Name: FDA 510(k) clearance K051513
Creator: U.S. Food and Drug Administration
Published: 2005-12-07

Substantially Equivalent

Bipore, Inc.

FDA 510(k) clearance K051513 for BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER, Substantially Equivalent on 2005-12-07. Applicant: Bipore, Inc.. Device class: 2.

Clearance details

Applicant: Bipore, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2005-06-02
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Northvale, NJ, US

Download summary PDF View on FDA.gov ↗

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K041293 — BIOPORE BALLOON DILATION CATHETER2004-07-09
K983650 — BIPORE BALLOON DILATATION CATHETER1999-02-17
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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.