NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER— 510(k) K953597

Substantially Equivalent

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K953597 for NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER, Substantially Equivalent on 1995-10-07. Applicant: Meadox Medicals, Div. Boston Scientific Corp..

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1995-08-01
Decision date: 1995-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

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Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.