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FDA 510(k)

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED

K-Number: K913312 · 1991-11-08

ApplicantTarget Therapeutics
Decision Date1991-11-08
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1991-11-08 under 510(k) number K913312. 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 HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED?

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-11-08. The listed applicant is Target Therapeutics. The 510(k) number is K913312.

When did HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED receive FDA 510(k) clearance?

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED received FDA 510(k) clearance on 1991-11-08, under 510(k) number K913312.

Who is the listed applicant for HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED?

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

What is the FDA product code for HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED?

The FDA product code for HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED is HCG.

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Other records listing Target Therapeutics as applicant

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K965071DETACHABLE SLICONE BALLOON (DSB)K964488DETACHABLE SILICONE BALLOON (DSB)K964210RETRIEVER IIK971395GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCEK965189SPINNAKERK964112BERENSTEIN COIL

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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