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FDA 510(k)

RENEGADE FIBER BRAIDED MICROCATHETER

K-Number: K973645 · 1997-11-19

ApplicantBoston Scientific Corp
Decision Date1997-11-19
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RENEGADE FIBER BRAIDED MICROCATHETER 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 1997-11-19 under 510(k) number K973645. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENEGADE FIBER BRAIDED MICROCATHETER?

RENEGADE FIBER BRAIDED MICROCATHETER is a medical device that received FDA 510(k) clearance on 1997-11-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K973645.

When did RENEGADE FIBER BRAIDED MICROCATHETER receive FDA 510(k) clearance?

RENEGADE FIBER BRAIDED MICROCATHETER received FDA 510(k) clearance on 1997-11-19, under 510(k) number K973645.

Who is the listed applicant for RENEGADE FIBER BRAIDED MICROCATHETER?

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 RENEGADE FIBER BRAIDED MICROCATHETER?

The FDA product code for RENEGADE FIBER BRAIDED MICROCATHETER is KRA.

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Other records listing Boston Scientific Corp as applicant

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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

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Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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