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

Name: FDA 510(k) clearance K030721
Creator: U.S. Food and Drug Administration
Published: 2003-03-31

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. Device class: 2.

Clearance details

Applicant: Ballard Medical Products
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
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 ↗

Recent devices under product code LRO

view all

K213481 — Medline General Surgery Tray2022-05-24
K212258 — Medline Cardiovascular Procedure Kit2021-12-03
K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL2004-11-30
K023276 — AMSINO TRACHEOSTOMY CARE TRAY2002-12-09
K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY1998-01-30

More clearances from Ballard Medical Products

view all

K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS2002-10-11
K013892 — LUTZ NEEDLE2002-07-11
K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES2000-03-28
K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT1999-10-20
K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME1999-05-03

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.