INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD— 510(k) K885179

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K885179 for INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD, Substantially Equivalent on 1989-08-09. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1988-12-14
Decision date: 1989-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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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.