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)

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS

K-Number: K082561 · 2008-12-10

ApplicantSpectranetics Corp.
Decision Date2008-12-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2008-12-10 under 510(k) number K082561. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS?

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS is a medical device that received FDA 510(k) clearance on 2008-12-10. The listed applicant is Spectranetics Corp.. The 510(k) number is K082561.

When did SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS receive FDA 510(k) clearance?

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS received FDA 510(k) clearance on 2008-12-10, under 510(k) number K082561.

Who is the listed applicant for SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS?

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 SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS?

The FDA product code for SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS is DQY.

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 ACCESSORYK094036TURBO-TANDEM SYSTEM MODEL 472-110K092378SPECTRANETICS VISISHEATH DILATOR SHEATHK092396SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

View all 23 devices →

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.

↑