TRACHE-TITE
FDA 510(k) clearance K950930 · decided 1995-03-22
Clearance details
- K-number
- K950930
- Device name
- TRACHE-TITE
- Applicant
- The Varner Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-01
- Decision date
- 1995-03-22
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- CBH
- Device class
- 1
- Regulation number
- 868.5770
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch The Varner Group
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (K140097) | Applied Medical Technology, Inc. | 2014-09-24 |
| DALE ENDOTRACHEAL TUBE HOLDER 270/280 (K964399) | Dale Medical Products, Inc. | 1997-01-28 |
| HCI TUBE STABILIZER (K942529) | Health Care Contracts, Inc. | 1995-06-14 |
| DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (K951491) | Dale Medical Products, Inc. | 1995-04-24 |
| FLEX BLUE (K950318) | King Systems Corp. | 1995-02-13 |
| ENDOTRACHEAL TUBE HOLDER (K942395) | S.T.I. Medical Products Corp. | 1994-06-30 |
| HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (K934288) | Neo-Tech, Inc. | 1994-06-09 |
| TRACH TIE, VENTILATOR TUBING HOLDER (K942016) | Garrett Medical Products | 1994-05-24 |
| TRAKEEZ (K941384) | Ergomed, Inc. | 1994-04-19 |
| NETOH ENDOTRACHEAL TUBE HOLDER (K940448) | Medical Accessory Services, Inc. | 1994-02-22 |
| PREPARE LOCK (K936094) | Prepare, Inc. | 1994-02-03 |
| STABILTRACH (K935171) | B&B Medical Technologies, Inc. | 1993-12-02 |
Recalls involving this device
No recalls on record reference this clearance.