Cleared Traditional

K884129 - BIO-MEDICUS PERCUTANEOUS CANNULA & INTR...

K884129 is the FDA 510(k) clearance for BIO-MEDICUS PERCUTANEOUS CANNULA & INTR... by Bio Medicus, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K884129 · Bio Medicus, Inc. · Cardiovascular device
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Dec 1988
Decision
82d
Days
Class 2
Risk

K884129 is an FDA 510(k) clearance for the BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bio Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 21, 1988 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Bio Medicus, Inc. devices

Submission Details

510(k) Number K884129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date December 21, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 582
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K884129.
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
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USCI CORONARY INFUSION CATHETER
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ACS SELECTIVE INFUSION CATHETER
K885237 · Advanced Cardiovascular Systems, Inc. · Mar 1989
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · Advanced Cardiovascular Systems, Inc. · Nov 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · Baxter Healthcare Corp · Oct 1988
VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT
K882969 · Gish Biomedical, Inc. · Sep 1988