Cleared Traditional

K211240 - ViperCross Support Catheters

K211240 is an FDA 510(k) clearance for ViperCross Support Catheters, manufactured by Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K211240 · Cardiovascular Systems, Inc. · Cardiovascular device
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Aug 2021
Decision
122d
Days
Class 2
Risk

K211240 is an FDA 510(k) clearance for the ViperCross Support Catheters. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cardiovascular Systems, Inc. (St.Paul, US). The FDA issued a Cleared decision on August 26, 2021 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Systems, Inc. devices

FDA 510(k) Submission Details - K211240

510(k) Number K211240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2021
Decision Date August 26, 2021
Days to Decision 122 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K211240.
Amplatzer Steerable Delivery Sheath
K212026 · Abbott Medical · Sep 2021
Amplatzer Talisman Delivery Sheath
K212738 · Abbott Medical · Sep 2021
ViperCross Support Catheters
K212725 · Cardiovascular Systems, Inc. · Sep 2021
WATCHMAN FXD Curve Access System
K212228 · Boston Scientific Corporation · Aug 2021
Rist 071 Radial Access Guide Catheter
K211990 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2021
ReCross
K210431 · Imds Operations B.V. · Jul 2021