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)

TURBO-TANDEM SYSTEM MODEL 472-110

K-Number: K094036 · 2010-01-25

ApplicantSpectranetics Corp.
Decision Date2010-01-25
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TURBO-TANDEM SYSTEM MODEL 472-110 is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2010-01-25 under 510(k) number K094036. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBO-TANDEM SYSTEM MODEL 472-110?

TURBO-TANDEM SYSTEM MODEL 472-110 is a medical device that received FDA 510(k) clearance on 2010-01-25. The listed applicant is Spectranetics Corp.. The 510(k) number is K094036.

When did TURBO-TANDEM SYSTEM MODEL 472-110 receive FDA 510(k) clearance?

TURBO-TANDEM SYSTEM MODEL 472-110 received FDA 510(k) clearance on 2010-01-25, under 510(k) number K094036.

Who is the listed applicant for TURBO-TANDEM SYSTEM MODEL 472-110?

The FDA 510(k) record lists Spectranetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TURBO-TANDEM SYSTEM MODEL 472-110?

The FDA product code for TURBO-TANDEM SYSTEM MODEL 472-110 is MCW.

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 Spectranetics Corp. 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.

K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035K1120328FR TURBO - TANDEM SYSTEMK093257TORQMAX SHEATH GRIP ACCESSORYK092378SPECTRANETICS VISISHEATH DILATOR SHEATHK092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERSK091299SPECTRANETICS TURBO-TANDEM SYSTEM

View all 23 devices →

Related Devices (Code: MCW)

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.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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.

↑