Cleared Traditional

K871132 - PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS

K871132 is an FDA 510(k) clearance for PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS, manufactured by Deltec Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K871132 · Deltec Systems, Inc. · Cardiovascular device
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Apr 1987
Decision
31d
Days
Class 2
Risk

K871132 is an FDA 510(k) clearance for the PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Deltec Systems, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 31 days - a notably fast clearance cycle.

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: 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 Deltec Systems, Inc. devices

FDA 510(k) Submission Details - K871132

510(k) Number K871132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1987
Decision Date April 20, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
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 645
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K871132.
OVAL PULL-APART SHEATH/DILATOR
K873394 · Quinton, Inc. · Sep 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER
K871140 · Aries Medical, Inc. · Apr 1987
INTRODUCER, PERCUTANEOUS
K870907 · Med Fusion Systems, Inc. · Apr 1987
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK
K870374 · Daig Corp. · Mar 1987
ARIES TAPERED SHEATH
K870189 · Aries Medical, Inc. · Mar 1987