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FDA 510(k)

ATLANTIS PVIMAGING CATHETER, MODEL H749364560

K-Number: K080272 · 2008-03-11

ApplicantBoston Scientific Corp
Decision Date2008-03-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATLANTIS PVIMAGING CATHETER, MODEL H749364560 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2008-03-11 under 510(k) number K080272. 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 ATLANTIS PVIMAGING CATHETER, MODEL H749364560?

ATLANTIS PVIMAGING CATHETER, MODEL H749364560 is a medical device that received FDA 510(k) clearance on 2008-03-11. The listed applicant is Boston Scientific Corp. The 510(k) number is K080272.

When did ATLANTIS PVIMAGING CATHETER, MODEL H749364560 receive FDA 510(k) clearance?

ATLANTIS PVIMAGING CATHETER, MODEL H749364560 received FDA 510(k) clearance on 2008-03-11, under 510(k) number K080272.

Who is the listed applicant for ATLANTIS PVIMAGING CATHETER, MODEL H749364560?

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

What is the FDA product code for ATLANTIS PVIMAGING CATHETER, MODEL H749364560?

The FDA product code for ATLANTIS PVIMAGING CATHETER, MODEL H749364560 is ITX.

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Related Devices (Code: ITX)

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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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