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FDA 510(k)

STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE

K-Number: K944729 · 1994-12-21

ApplicantCoast Medical, Inc.
Decision Date1994-12-21
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Coast Medical, Inc.. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K944729. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE?

STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Coast Medical, Inc.. The 510(k) number is K944729.

When did STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE receive FDA 510(k) clearance?

STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE received FDA 510(k) clearance on 1994-12-21, under 510(k) number K944729.

Who is the listed applicant for STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE?

The FDA 510(k) record lists Coast Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE?

The FDA product code for STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE is BSR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Coast Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952243EXTENSION SET/I.V. SETK943270SURFACE TEMPERATURE PROBESK943495DISPOSABLE ESOPHAGEAL STETHOSCOPEK943110GAS SAMPLING INTERFACES

Related Devices (Code: BSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook IncorporatedK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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