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FDA 510(k)

BARD PLAQUE ELECTRODE ARRAY

K-Number: K893611 · 1989-07-14

ApplicantBard Electrophysiology
Decision Date1989-07-14
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD PLAQUE ELECTRODE ARRAY is the device name listed in this FDA 510(k) record. The listed applicant is Bard Electrophysiology. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K893611. 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 BARD PLAQUE ELECTRODE ARRAY?

BARD PLAQUE ELECTRODE ARRAY is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Bard Electrophysiology. The 510(k) number is K893611.

When did BARD PLAQUE ELECTRODE ARRAY receive FDA 510(k) clearance?

BARD PLAQUE ELECTRODE ARRAY received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893611.

Who is the listed applicant for BARD PLAQUE ELECTRODE ARRAY?

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

What is the FDA product code for BARD PLAQUE ELECTRODE ARRAY?

The FDA product code for BARD PLAQUE ELECTRODE ARRAY 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 Bard Electrophysiology 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.

K042105CLIPPER DIAGNOSTIC ELECTRODE CATHETERK913875BARD(R) BIOPOTENTIAL AMPLIFIER II

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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