Cleared Abbreviated

K070002 - BOSTON SCIENTIFIC PERIPHERALLY INSERTED...

K070002 is the FDA 510(k) clearance for BOSTON SCIENTIFIC PERIPHERALLY INSERTED... by Boston Scientific. It is a Class 2 General Hospital device (product code LJS) cleared through the Abbreviated 510(k) pathway after a 226-day FDA review.

K070002 · Boston Scientific · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
226d
Days
Class 2
Risk

K070002 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Boston Scientific (Marlboro, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 226 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Boston Scientific devices

Submission Details

510(k) Number K070002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date August 17, 2007
Days to Decision 226 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 129d · This submission: 226d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 180
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K070615 · AngioDynamics, Inc. · May 2007