Cleared Traditional

K884478 - DAIG COLLAPSIBLE STERILE SLEEVE

K884478 is an FDA 510(k) clearance for DAIG COLLAPSIBLE STERILE SLEEVE, manufactured by Daig Corp.. The device is a Class 2 Cardiovascular device with product code DQR cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K884478 · Daig Corp. · Cardiovascular device
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Feb 1989
Decision
120d
Days
Class 2
Risk

K884478 is an FDA 510(k) clearance for the DAIG COLLAPSIBLE STERILE SLEEVE. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on February 22, 1989 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 Daig Corp. devices

FDA 510(k) Submission Details - K884478

510(k) Number K884478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1988
Decision Date February 22, 1989
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQR Device Classification - Class 2, Special Controls

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

All 19
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K884478.
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · Datascope Corp. · Jan 1991
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · Shiley, Inc. · Mar 1990
RMI ARTERIAL PERFUSION CANNULA
K894243 · Research Medical, Inc. · Sep 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · Argon Medical Corp. · Jan 1989
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · Medsurg Industries, Inc. · May 1988
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
K880776 · Medsurg Industries, Inc. · May 1988