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FDA 510(k)

Pinpoint GT Needle Guide Kits

K-Number: K171348 · 2017-05-22

ApplicantC.R. Bard, Inc.
Decision Date2017-05-22
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pinpoint GT Needle Guide Kits is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-05-22 under approval number K171348. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pinpoint GT Needle Guide Kits?

Pinpoint GT Needle Guide Kits is a medical device that received FDA 510(k) clearance on 2017-05-22. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K171348.

When was Pinpoint GT Needle Guide Kits approved by the FDA?

Pinpoint GT Needle Guide Kits received FDA 510(k) clearance on 2017-05-22, under approval number K171348.

What company makes Pinpoint GT Needle Guide Kits?

Pinpoint GT Needle Guide Kits is manufactured by C.R. Bard, Inc..

What is the FDA product code for Pinpoint GT Needle Guide Kits?

The FDA product code for Pinpoint GT Needle Guide Kits is ITX.

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Other Devices by C.R. Bard, Inc.

K162900PowerMidline Catheter K162894AccuCath Intravascular Catheter K162769Pinpoint GT Introducer Needle K162443PowerPICC Provena Catheters K161424Phasix Mesh K162377PowerGlide Pro Midline Catheter

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Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

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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