Cleared Traditional

K980566 - VAXESS PERIPHERALLY INSERTED CENTRAL CA...

K980566 is the FDA 510(k) clearance for VAXESS PERIPHERALLY INSERTED CENTRAL CA... by Boston Scientific Corp. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K980566 · Boston Scientific Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
213d
Days
Class 2
Risk

K980566 is an FDA 510(k) clearance for the VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 213 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K980566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1998
Decision Date September 14, 1998
Days to Decision 213 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
84d slower than avg
Panel avg: 129d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K980566.
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
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INTROCAN SAFETY IV CATHETER
K982805 · B.Braun Medical, Inc. · Jan 1999
BRAUN PREFILLED SYRINGE
K970736 · B.Braun Medical, Inc. · Dec 1998
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
K974015 · Davis & Geck, Inc. · May 1998
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
K973561 · Medical Components, Inc. · May 1998
I.V. CATHETER SYSTEM
K980493 · Johnson & Johnson Medical, Inc. · Apr 1998