QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE— 510(k) K030721

Substantially Equivalent

Ballard Medical Products

FDA 510(k) clearance K030721 for QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE, Substantially Equivalent on 2003-03-31. Applicant: Ballard Medical Products.

Clearance details

Applicant: Ballard Medical Products
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 2003-03-07
Decision date: 2003-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.