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FDA 510(k)

CONTOUR EMBOLI

K-Number: K944354 · 1994-12-13

ApplicantInterventional Therapeutics Corp.
Decision Date1994-12-13
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CONTOUR EMBOLI is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1994-12-13 under 510(k) number K944354. 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 CONTOUR EMBOLI?

CONTOUR EMBOLI is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K944354.

When did CONTOUR EMBOLI receive FDA 510(k) clearance?

CONTOUR EMBOLI received FDA 510(k) clearance on 1994-12-13, under 510(k) number K944354.

Who is the listed applicant for CONTOUR EMBOLI?

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

What is the FDA product code for CONTOUR EMBOLI?

The FDA product code for CONTOUR EMBOLI is HCG.

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Other records listing Interventional Therapeutics 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.

K960832OCCLUSION BALLOON CATHETERK950398CATHETER, BALLOON TYPEK945588DISPOSABLE 1CC SYRINGE WITH LUER LOCKK930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATORK914866ITC CONTOUR EMBOLI, MODIFICATIONK931025INTHERM STASIS VALVE SYSTEM

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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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