R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD— 510(k) K935371

Substantially Equivalent

R2 Medical Systems

FDA 510(k) clearance K935371 for R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD, Substantially Equivalent on 1994-12-02. Applicant: R2 Medical Systems.

Clearance details

Applicant: R2 Medical Systems
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1993-11-08
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.