Cleared Traditional

K982888 - VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM

K982888 is the FDA 510(k) clearance for VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM by Boston Scientific Corp. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K982888 · Boston Scientific Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
64d
Days
Class 2
Risk

K982888 is an FDA 510(k) clearance for the VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on October 20, 1998 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K982888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1998
Decision Date October 20, 1998
Days to Decision 64 days
Submission Type Traditional
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
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 109
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K982888.
VAXCEL WITH PASV PORT
K030083 · Boston Scientific Corp · Jan 2003
BARDPORT X-PORT ISP PORT
K022983 · C.R. Bard, Inc. · Sep 2002
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006 · Arrow Intl., Inc. · Oct 2000
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538 · Boston Scientific Corp · Mar 1997
DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
K964066 · C.R. Bard, Inc. · Mar 1997
CELSITE PORT WITH PRECONNECTED CATHETER
K962230 · B.Braun Medical, Inc. · Dec 1996