Cleared Traditional

K963988 - INTRAVASCULAR INFUSION DEVICE

K963988 is the FDA 510(k) clearance for INTRAVASCULAR INFUSION DEVICE by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K963988 · Boston Scientific Corp · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
69d
Days
Class 2
Risk

K963988 is an FDA 510(k) clearance for the INTRAVASCULAR INFUSION DEVICE. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on December 12, 1996 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight 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 K963988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date December 12, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K963988.
CONTINUOUS FLUSH DEVICE
K962129 · Merit Medical Systems, Inc. · Apr 1997
SPINNAKER
K965189 · Target Therapeutics · Mar 1997
CES INFUSION CATHETER
K965181 · Cordis Neurovascular, Inc. · Mar 1997
MICROFERRET CATHETER
K961668 · Cook, Inc. · Nov 1996
SCIMED DISPATCH GOLD CORONARY CATHETER
K961294 · Scimed Life Systems, Inc. · Jul 1996
MX703 AND MX730 CONTINUOUS FLUSH DEVICES
K961527 · Medex, Inc. · Jun 1996