CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350— 510(k) K023337

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K023337 for CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350, Substantially Equivalent on 2002-11-18. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code KTI
Advisory panel: Ear, Nose, Throat
Date received: 2002-10-07
Decision date: 2002-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.