Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EXTENSION SET/I.V. SET

K-Number: K952243 · 1995-07-26

ApplicantCoast Medical, Inc.
Decision Date1995-07-26
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXTENSION SET/I.V. SET 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 1995-07-26 under 510(k) number K952243. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENSION SET/I.V. SET?

EXTENSION SET/I.V. SET is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Coast Medical, Inc.. The 510(k) number is K952243.

When did EXTENSION SET/I.V. SET receive FDA 510(k) clearance?

EXTENSION SET/I.V. SET received FDA 510(k) clearance on 1995-07-26, under 510(k) number K952243.

Who is the listed applicant for EXTENSION SET/I.V. SET?

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 EXTENSION SET/I.V. SET?

The FDA product code for EXTENSION SET/I.V. SET is FPK.

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.

K944729STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCEK943270SURFACE TEMPERATURE PROBESK943495DISPOSABLE ESOPHAGEAL STETHOSCOPEK943110GAS SAMPLING INTERFACES

Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.

Official Source

View on FDA Database →

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

↑