POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF— 510(k) K912076

Substantially Equivalent

The R Group

FDA 510(k) clearance K912076 for POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF, Substantially Equivalent on 1991-07-30. Applicant: The R Group.

Clearance details

Applicant: The R Group
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1991-05-10
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesvilles, FL, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.