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FDA 510(k)

DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)

K-Number: K951256 · 1995-09-08

ApplicantTarget Therapeutics
Decision Date1995-09-08
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K951256. 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 DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)?

DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Target Therapeutics. The 510(k) number is K951256.

When did DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) receive FDA 510(k) clearance?

DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) received FDA 510(k) clearance on 1995-09-08, under 510(k) number K951256.

Who is the listed applicant for DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)?

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 DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)?

The FDA product code for DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) is HCG.

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Other records listing Target Therapeutics 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.

K964488DETACHABLE SILICONE BALLOON (DSB)K965071DETACHABLE SLICONE 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

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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