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FDA 510(k)

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER

K-Number: K070002 · 2007-08-17

ApplicantBoston Scientific
Decision Date2007-08-17
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K070002. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER?

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is Boston Scientific. The 510(k) number is K070002.

When did BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER receive FDA 510(k) clearance?

BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER received FDA 510(k) clearance on 2007-08-17, under 510(k) number K070002.

Who is the listed applicant for BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER?

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

What is the FDA product code for BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER?

The FDA product code for BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER is LJS.

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Related Devices (Code: LJS)

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K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo 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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