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)

A LITHOTRIPTER-COMPATIBLE BASKET

K-Number: K964937 · 1997-01-24

ApplicantBoston Scientific Corp
Decision Date1997-01-24
Product CodeLQC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

A LITHOTRIPTER-COMPATIBLE BASKET is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964937. The device is classified under product code LQC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A LITHOTRIPTER-COMPATIBLE BASKET?

A LITHOTRIPTER-COMPATIBLE BASKET is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Boston Scientific Corp. The 510(k) number is K964937.

When did A LITHOTRIPTER-COMPATIBLE BASKET receive FDA 510(k) clearance?

A LITHOTRIPTER-COMPATIBLE BASKET received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964937.

Who is the listed applicant for A LITHOTRIPTER-COMPATIBLE BASKET?

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

What is the FDA product code for A LITHOTRIPTER-COMPATIBLE BASKET?

The FDA product code for A LITHOTRIPTER-COMPATIBLE BASKET is LQC.

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 Boston Scientific 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.

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

View all 414 devices →

Related Devices (Code: LQC)

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.

K040447TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088Boston Scientific CorpK011178WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTORWilson-Cook Medical, Inc.K942544GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETSMedi-Globe Corp.K943191MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTORBoston Scientific CorpK905552LAPAROLITHBaxter Healthcare CorpK911364SPOON FORCEPS, 11MMNorthgate Technologies, 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.

↑