72 Hour Use Trach Care with Microban
FDA 510(k) K974630 · Ballard Medical Products
510(k) numberK974630
Submission
- Device name
- 72 Hour Use Trach Care with Microban
- Applicant
- Ballard Medical Products
Draper, UT, US - Received
- December 12, 1997
- Decision date
- March 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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More from Great Group Medical Co, Ltd.
| 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 |
| 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 72 Hour Use Trach Care with Microban cleared by the FDA?
72 Hour Use Trach Care with Microban (K974630) received a 510(k) decision of Substantially Equivalent on March 11, 1998, 89 days after the submission was received.
What is the product code of K974630?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.