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)

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

K-Number: K971504 · 1998-04-20

ApplicantJ-Lloyd Medical, Inc.
Decision Date1998-04-20
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is J-Lloyd Medical, Inc.. It received FDA 510(k) clearance on 1998-04-20 under 510(k) number K971504. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER?

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER is a medical device that received FDA 510(k) clearance on 1998-04-20. The listed applicant is J-Lloyd Medical, Inc.. The 510(k) number is K971504.

When did HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER receive FDA 510(k) clearance?

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER received FDA 510(k) clearance on 1998-04-20, under 510(k) number K971504.

Who is the listed applicant for HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER?

The FDA 510(k) record lists J-Lloyd Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER?

The FDA product code for HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER is DRF.

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 J-Lloyd 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.

K973639ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.K974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K974335EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K963248FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)K950440DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYDK940547FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED

View all 16 devices →

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, 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.

↑