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FDA 510(k)

BLAZER DX-20 DIAGNOSTIC CATHETER

K-Number: K081576 · 2009-02-03

ApplicantBoston Scientific Corp
Decision Date2009-02-03
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLAZER DX-20 DIAGNOSTIC CATHETER 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 2009-02-03 under 510(k) number K081576. 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 BLAZER DX-20 DIAGNOSTIC CATHETER?

BLAZER DX-20 DIAGNOSTIC CATHETER is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K081576.

When did BLAZER DX-20 DIAGNOSTIC CATHETER receive FDA 510(k) clearance?

BLAZER DX-20 DIAGNOSTIC CATHETER received FDA 510(k) clearance on 2009-02-03, under 510(k) number K081576.

Who is the listed applicant for BLAZER DX-20 DIAGNOSTIC CATHETER?

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 BLAZER DX-20 DIAGNOSTIC CATHETER?

The FDA product code for BLAZER DX-20 DIAGNOSTIC CATHETER is DRF.

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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.

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