Cleared Special

K093050 - ARROW SELDINGER ARTERIAL CATHERIZATION ...

K093050 is an FDA 510(k) clearance for ARROW SELDINGER ARTERIAL CATHERIZATION ..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 79-day FDA review.

K093050 · Arrow Intl., Inc. · Cardiovascular device
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Dec 2009
Decision
79d
Days
Class 2
Risk

K093050 is an FDA 510(k) clearance for the ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520. 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 December 18, 2009 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K093050

510(k) Number K093050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date December 18, 2009
Days to Decision 79 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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 599
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