InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)— 510(k) K150322

Substantially Equivalent

Pan Medical , Ltd.

FDA 510(k) clearance K150322 for InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm), Substantially Equivalent on 2015-03-06. Applicant: Pan Medical , Ltd..

Clearance details

Applicant: Pan Medical , Ltd.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2015-02-09
Decision date: 2015-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.