Quick-Tap Paracentesis Tray, Kit & Needle
FDA 510(k) K030721 · Ballard Medical Products
510(k) numberK030721
Submission
- Device name
- Quick-Tap Paracentesis Tray, Kit & Needle
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- March 7, 2003
- Decision date
- March 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRO – General Surgery Tray
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Other 510(k)s with product code LRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213481 | Medline General Surgery TrayLRO · Traditional | Medline Industries, Inc. | 05/24/2022SE |
| K212258 | Medline Cardiovascular Procedure KitLRO · Traditional | Medline Industries, Inc. | 12/03/2021SE |
| K041080 | Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional | D.I.R.R.A. S.R.L. | 11/30/2004SE |
| K023276 | Amsino Tracheostomy Care TrayLRO · Traditional | Amsino International, Inc. | 12/09/2002SE |
| K980137 | Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional | Worldwide Medical Technologies, LLC | 01/30/1998SE |
| K971061 | Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional | Opportunity, Inc. | 06/11/1997SN |
| K971062 | Opportunity Inc. General Purpose TrayLRO · Traditional | Opportunity, Inc. | 06/09/1997SN |
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | Associated Medical Products Co. | 03/19/1997SE |
| K970286 | Presbyterian Linen Services Surgical PacksLRO · Traditional | Medline Industries, Inc. | 03/10/1997SE |
| K970187 | Runyon Large Volume Paracentesis KitLRO · Traditional | Gi Supply | 02/14/1997SE |
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| K022398 | Reusable Bronchial Biopsy ForcepsBWH · Traditional | 10/11/2002SE |
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| K000495 | Ballard Medical Products Epidural and Spinal NeedlesBSP · Traditional | 03/28/2000SE |
| K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement KitKNT · Special | 10/20/1999SE |
| K990376 | Ballard Medical Products Faciletome Bow String PapillotomeKNS · Traditional | 05/03/1999SE |
| K982894 | Mic-Key Glow Profile Gastrostomy Replacement KitKNT · Special | 09/11/1998SE |
| K974630 | 72 Hour Use Trach Care with MicrobanCAH · Traditional | 03/11/1998SE |
| K964369 | Trach Care Set with MicrobanBSY · Traditional | 02/11/1997SE |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | 07/05/1995SE |
| K923487 | Bal CathKTR · Traditional | 07/30/1993SESK |
Questions and answers
When was Quick-Tap Paracentesis Tray, Kit & Needle cleared by the FDA?
Quick-Tap Paracentesis Tray, Kit & Needle (K030721) received a 510(k) decision of Substantially Equivalent on March 31, 2003, 24 days after the submission was received.
What is the product code of K030721?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.