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FDA 510(k)

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM

K-Number: K133208 · 2013-11-14

ApplicantBoston Scientific Corp
Decision Date2013-11-14
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM 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 2013-11-14 under 510(k) number K133208. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM?

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-14. The listed applicant is Boston Scientific Corp. The 510(k) number is K133208.

When did INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM receive FDA 510(k) clearance?

INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM received FDA 510(k) clearance on 2013-11-14, under 510(k) number K133208.

Who is the listed applicant for INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM?

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 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM?

The FDA product code for INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM is KRD.

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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 PLUSK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEMK132990OCCLUSION BALLOON CATHETER

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Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, 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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