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FDA 510(k)

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT

K-Number: K042445 · 2004-10-19

ApplicantBard Access Systems, Inc.
Decision Date2004-10-19
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2004-10-19 under 510(k) number K042445. 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 SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT?

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT is a medical device that received FDA 510(k) clearance on 2004-10-19. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K042445.

When did SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT receive FDA 510(k) clearance?

SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT received FDA 510(k) clearance on 2004-10-19, under 510(k) number K042445.

Who is the listed applicant for SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT?

The FDA product code for SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT is ITX.

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Other records listing Bard Access Systems, Inc. as applicant

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K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortK251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortK241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetK242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsK240146BD Prevue™ II Peripheral Vascular Access SystemK222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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