Aga Trach Ties
FDA 510(k) K922657 · Aga Medical Products, Inc.
510(k) numberK922657
Submission
- Device name
- Aga Trach Ties
- Applicant
- Aga Medical Products, Inc.
Malvern, PA, US - Received
- June 3, 1992
- Decision date
- July 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBH – Device, Fixation, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5770
- Specialty
- Anesthesiology
Other 510(k)s with product code CBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140097 | Amt Endotracheal Tube Bridle Retention SystemCBH · Traditional | Applied Medical Technology, Inc. | 09/24/2014SE |
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | Dale Medical Products, Inc. | 01/28/1997SE |
| K942529 | Hci Tube StabilizerCBH · Traditional | Health Care Contracts, Inc. | 06/14/1995SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | Dale Medical Products, Inc. | 04/24/1995SE |
| K950930 | Trache-TiteCBH · Traditional | The Varner Group, Inc. | 03/22/1995SE |
| K950318 | Flex BlueCBH · Traditional | King Systems Corp. | 02/13/1995SE |
| K942395 | Endotracheal Tube HolderCBH · Traditional | S.T.I. Medical Products Corp. | 06/30/1994SE |
| K934288 | Holde.T. Endotracheal Tube Stabilization BarCBH · Traditional | Neo-Tech, Inc. | 06/09/1994SE |
| K942016 | Trach Tie, Ventilator Tubing HolderCBH · Traditional | Garrett Medical Products | 05/24/1994SE |
| K941384 | TrakeezCBH · Traditional | Ergomed, Inc. | 04/19/1994SE |
More from Ergomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925438 | Combination Trach Tie & Ventilator AntidisconnectJOH · Traditional | 02/17/1993SE |
Questions and answers
When was Aga Trach Ties cleared by the FDA?
Aga Trach Ties (K922657) received a 510(k) decision of Substantially Equivalent on July 2, 1992, 29 days after the submission was received.
What is the product code of K922657?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.