Trach Care Set with Microban
FDA 510(k) K964369 · Ballard Medical Products
510(k) numberK964369
Submission
- Device name
- Trach Care Set with Microban
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- November 1, 1996
- Decision date
- February 11, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BSY – Catheters, Suction, Tracheobronchial
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6810
- Specialty
- Anesthesiology
Other 510(k)s with product code BSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031997 | Mallinckrodt Dar Ty-Care / Ty-Care Exel Closed Suction SystemBSY · Traditional | Mallinckrodt Dar S.R.L. | 11/25/2003SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | Ambu, Inc. | 10/25/1999SE |
| K982945 | Dual Purpose Closed CatheterBSY · Traditional | Spirit Medical Systems, Inc. | 09/22/1998SE |
| K981910 | Suction CatheterBSY · Traditional | Ni-Med, Inc. | 08/24/1998SE |
| K972258 | Hi-Care Closed Suction SystemBSY · Traditional | Mallinckrodt Medical | 12/29/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | Amsino Intl., Inc. | 09/10/1997SE |
| K961707 | Trach-Eze Closed Ventilation Suction SystemBSY · Traditional | Sorenson Critical Care | 03/11/1997SE |
| K960488 | Neo 2 Line Suction SystemBSY · Traditional | Alcove Medical, Inc. | 04/26/1996SE |
| K955831 | Argyle Aspr-Care Closed Suction SystemBSY · Traditional | Sherwood Medical Co. | 03/28/1996SE |
| K955645 | Cath-GuideBSY · Traditional | Hudson Respiratory Care, Inc. | 03/12/1996SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K030721 | Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special | 03/31/2003SE |
| K022398 | Reusable Bronchial Biopsy ForcepsBWH · Traditional | 10/11/2002SE |
| K013892 | Lutz NeedleBSP · Traditional | 07/11/2002SE |
| 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 |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage KitKDH · Traditional | 07/05/1995SE |
| K923487 | Bal CathKTR · Traditional | 07/30/1993SESK |
Questions and answers
When was Trach Care Set with Microban cleared by the FDA?
Trach Care Set with Microban (K964369) received a 510(k) decision of Substantially Equivalent on February 11, 1997, 102 days after the submission was received.
What is the product code of K964369?
The FDA product code is BSY – Catheters, Suction, Tracheobronchial, a Class I (low risk) device regulated under 21 CFR 868.6810.