STABILTRACH
FDA 510(k) clearance K935171 · decided 1993-12-02
Clearance details
- K-number
- K935171
- Device name
- STABILTRACH
- Applicant
- B&B Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-26
- Decision date
- 1993-12-02
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- CBH
- Device class
- 1
- Regulation number
- 868.5770
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orangevale, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |
| TRACHE-TITE (K950930) | The Varner Group, Inc. | 1995-03-22 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.