Cleared Traditional

K882097 - TUNNELING STYLET

K882097 is an FDA 510(k) clearance for TUNNELING STYLET, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K882097 · Quinton, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
70d
Days
Class 2
Risk

K882097 is an FDA 510(k) clearance for the TUNNELING STYLET. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K882097

510(k) Number K882097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date July 28, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 22
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K882097.
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · Spectranetics Corp. · Oct 1999
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · Target Therapeutics · Nov 1991
LEAD STYLET
K905674 · Cardiac Pacemakers, Inc. · Jan 1991
STIFF STYLETS
K802076 · Cardiac Pacemakers, Inc. · Sep 1980
OBTURATOR
K770404 · Abbott Laboratories · Mar 1977