MEMOTHERM COLORECTAL STENT— 510(k) K990504

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K990504 for MEMOTHERM COLORECTAL STENT, Substantially Equivalent on 2000-03-16. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 1999-02-17
Decision date: 2000-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

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Adverse events under product code MQR

product code MQR

Death: 11
Injury: 149
Total: 160

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.