STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
FDA 510(k) clearance K944729 · decided 1994-12-21
Clearance details
- K-number
- K944729
- Device name
- STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE
- Applicant
- Coast Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-26
- Decision date
- 1994-12-21
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- BSR
- Device class
- 1
- Regulation number
- 868.5790
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orange, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coast Medical
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to ai recall (Z-1556-2015) | Vital Signs Colorado Inc. | 2015-04-30 |
| Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation pr recall (Z-1557-2015) | Vital Signs Colorado Inc. | 2015-04-30 |
| Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado In recall (Z-2454-2008) | Vital Signs Colorado Inc. | 2008-09-21 |
| Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Engle recall (Z-2455-2008) | Vital Signs Colorado Inc. | 2008-09-21 |
| Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, recall (Z-2456-2008) | Vital Signs Colorado Inc. | 2008-09-21 |