Cleared Traditional

K820648 - ARROW M.I.S. MULTI-LUMEN CATHETERIZA

K820648 is an FDA 510(k) clearance for ARROW M.I.S. MULTI-LUMEN CATHETERIZA, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K820648 · Arrow Intl., Inc. · Cardiovascular device
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Apr 1982
Decision
36d
Days
Class 2
Risk

K820648 is an FDA 510(k) clearance for the ARROW M.I.S. MULTI-LUMEN CATHETERIZA. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Walker, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 36 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K820648

510(k) Number K820648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1982
Decision Date April 14, 1982
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 600
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K820648.
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · Advanced Cardiovascular Systems, Inc. · Nov 1982
MULTIPURPOSE CATHETER
K821189 · Advanced Cardiovascular Systems, Inc. · Jul 1982
RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
K821480 · The Healthcare Group Laboratories, Inc. · Jun 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · Arrow Intl., Inc. · Jan 1982
EDSLAB CATHETER COVER
K813514 · American Edwards Laboratories · Dec 1981
CORDIS DUCOR PTR SYSTEM
K811971 · Cordis Corp. · Aug 1981