Cleared Traditional

K912645 - ATRIUMS PDR THORACIC CATHETER

K912645 is an FDA 510(k) clearance for ATRIUMS PDR THORACIC CATHETER, manufactured by Atrium Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K912645 · Atrium Medical Corp. · General & Plastic Surgery device
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Sep 1991
Decision
88d
Days
Class 1
Risk

K912645 is an FDA 510(k) clearance for the ATRIUMS PDR THORACIC CATHETER. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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: 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K912645

510(k) Number K912645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1991
Decision Date September 13, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

GBS Device Classification - Class 1, General Controls

Product Code GBS Catheter, Ventricular, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBS Catheter, Ventricular, General & Plastic Surgery

All 18
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K912645.
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873 · Sheridan Catheter Corp. · May 1988
URESIL WOUND DRAIN TROCAR
K880895 · Uresil Corp. · Mar 1988
CLOSED CHEST DRAINAGE SET W/SUTURES
K873377 · Gish Biomedical, Inc. · Oct 1987
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560 · Uresil Corp. · Sep 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142 · Sheridan Catheter Corp. · Aug 1986
AXIOM TROCAR THORACIC CATHETER
K863247 · Axiom Medical, Inc. · Aug 1986