Cleared Traditional

K961499 - LAGUNA SOFTIP DIAGNOSTIC CATHETERS

K961499 is an FDA 510(k) clearance for LAGUNA SOFTIP DIAGNOSTIC CATHETERS, manufactured by Boston Scientific Scimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K961499 · Boston Scientific Scimed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
182d
Days
Class 2
Risk

K961499 is an FDA 510(k) clearance for the LAGUNA SOFTIP DIAGNOSTIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 17, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Scimed, Inc. devices

FDA 510(k) Submission Details - K961499

510(k) Number K961499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1996
Decision Date October 17, 1996
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K961499.
MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
K963092 · Adam Spencer Corp. · Jan 1997
ASC HIGH PRESSURE BRAIDED TUBES
K964331 · Adam Spencer Corp. · Jan 1997
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
K960056 · C.R. Bard, Inc. · Oct 1996
SPYGLASS ANGIOGRAPHIC CATHETER
K962805 · Daig Corp. · Oct 1996
4F NYLEX ANGIOGRAPHIC CATHETER
K962759 · Cordis Corp. · Oct 1996
TURBO TRACKER
K960806 · Target Therapeutics · May 1996