Cleared Special

K032375 - VAXCEL PORT, MODELS 45-336 AND 45-338

K032375 is an FDA 510(k) clearance for VAXCEL PORT, manufactured by Boston Scientific Corp. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 18-day FDA review.

K032375 · Boston Scientific Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
18d
Days
Class 2
Risk

K032375 is an FDA 510(k) clearance for the VAXCEL PORT, MODELS 45-336 AND 45-338. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Glens Falls, US). The FDA issued a Cleared decision on August 19, 2003 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K032375

510(k) Number K032375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date August 19, 2003
Days to Decision 18 days
Submission Type Special
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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K032375.
VORTEX MP
K032754 · Horizon Medical Products, Inc. · Sep 2003
TRIUMPH VTX WITH LIFEVALVE CATHETER
K032557 · Horizon Medical Products, Inc. · Sep 2003
VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
K032600 · Boston Scientific Corp · Sep 2003
OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
K031282 · LeMaitre Vascular, Inc. · Aug 2003
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
K031844 · Boston Scientific Corp · Jul 2003
VAXCEL WITH PASV PORT, MODEL 45-213
K032008 · Boston Scientific Corp · Jul 2003