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FDA 510(k)

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)

K-Number: K964021 · 1997-03-27

ApplicantBaxter Edwards
Decision Date1997-03-27
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1997-03-27 under 510(k) number K964021. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)?

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) is a medical device that received FDA 510(k) clearance on 1997-03-27. The listed applicant is Baxter Edwards. The 510(k) number is K964021.

When did INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) receive FDA 510(k) clearance?

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) received FDA 510(k) clearance on 1997-03-27, under 510(k) number K964021.

Who is the listed applicant for INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)?

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

What is the FDA product code for INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)?

The FDA product code for INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) is HCG.

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Other records listing Baxter Edwards as applicant

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K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK981909BAXTER HEMOSTASIS VALVE INTRODUCERSK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK965137FOGARTY VALVULOTOME MODEL 700091K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETERK9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

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Related Devices (Code: HCG)

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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

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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