STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE— 510(k) K944729
Substantially EquivalentCoast Medical, Inc.
FDA 510(k) clearance K944729 for STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE, Substantially Equivalent on 1994-12-21. Applicant: Coast Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Coast Medical, Inc.
- Product code
- Code BSR
- Device class
- Class 1
- Regulation
- 21 CFR 868.5790
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange, CA, US
Recent devices under product code BSR
view all- K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
- K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- K943104 — MOLLOY INTUBATING STYLETTE
- K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
More clearances from Coast Medical, Inc.
view allAdverse events under product code BSR
product code BSR- Death
- 2
- Other
- 1
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K944729
K-number listed on FDA's recall record- Z-1556-2015 — CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
- Z-1557-2015 — Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944729.
Data sourced from openFDA. This site is unofficial and independent of the FDA.