Cleared Traditional

K862056 - [CENTRAL VENOUS][MULTI-LUMEN] CATHETER ...

K862056 is an FDA 510(k) clearance for [CENTRAL VENOUS][MULTI-LUMEN] CATHETER ..., 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 87-day FDA review.

K862056 · Arrow Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
87d
Days
Class 2
Risk

K862056 is an FDA 510(k) clearance for the [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on August 25, 1986 after a review of 87 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 - K862056

510(k) Number K862056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date August 25, 1986
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 K862056.
TRACKER INFUSION CATHETER
K862117 · Target Therapeutics · Oct 1986
MODIFIED PTCA GUIDING CATHETERS
K862975 · Cordis Corp. · Sep 1986
MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS
K863322 · Quinton, Inc. · Sep 1986
CURITY CENTRAL VENOUS CATHETERIZATION TRAY
K861827 · The Kendal Co. · Jul 1986
CURITY VENOUS CATHETERIZATION KIT
K861828 · The Kendal Co. · Jul 1986
CURITY CENTRAL VENOUS CATHETER
K861829 · The Kendal Co. · Jul 1986