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FDA 510(k)

MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER

K-Number: K955111 · 1996-01-31

ApplicantAdam Spence Corp.
Decision Date1996-01-31
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Adam Spence Corp.. It received FDA 510(k) clearance on 1996-01-31 under 510(k) number K955111. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER?

MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Adam Spence Corp.. The 510(k) number is K955111.

When did MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1996-01-31, under 510(k) number K955111.

Who is the listed applicant for MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER?

The FDA product code for MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER is DQO.

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 Adam Spence 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.

K983940EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATORK950855ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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