Cleared Traditional

K982797 - BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

K982797 is an FDA 510(k) clearance for BLUNT T-PEEL INTRODUCER MODEL NUMBER PE..., manufactured by Luther Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K982797 · Luther Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
112d
Days
Class 2
Risk

K982797 is an FDA 510(k) clearance for the BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Luther Medical Products, Inc. (Tustin, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Luther Medical Products, Inc. devices

FDA 510(k) Submission Details - K982797

510(k) Number K982797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date November 30, 1998
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 625
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K982797.
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
K984062 · Diag Corp. · Mar 1999
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · Terumo Medical Corp. · Jan 1999
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · Cordis Corp. · Dec 1998
BAXTER HEMOSTASIS VALVE INTRODUCERS
K981909 · Baxter Edwards · Nov 1998
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · Cordis Corp. · Oct 1998
FAST-CATH INTRA-CARDIAC INTRODUCER
K982187 · Daig Corp. · Sep 1998