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FDA 510(k)

INTRAVASCULAR INFUSION DEVICE

K-Number: K963988 · 1996-12-12

ApplicantBoston Scientific Corp
Decision Date1996-12-12
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR INFUSION DEVICE 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 1996-12-12 under 510(k) number K963988. 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 INTRAVASCULAR INFUSION DEVICE?

INTRAVASCULAR INFUSION DEVICE is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Boston Scientific Corp. The 510(k) number is K963988.

When did INTRAVASCULAR INFUSION DEVICE receive FDA 510(k) clearance?

INTRAVASCULAR INFUSION DEVICE received FDA 510(k) clearance on 1996-12-12, under 510(k) number K963988.

Who is the listed applicant for INTRAVASCULAR INFUSION DEVICE?

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 INTRAVASCULAR INFUSION DEVICE?

The FDA product code for INTRAVASCULAR INFUSION DEVICE is KRA.

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Other records listing Boston Scientific Corp 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.

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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