Cleared Traditional

K241611 - ShapeIT (SI014135)

K241611 is an FDA 510(k) clearance for ShapeIT (SI014135), manufactured by Imds Operations B.V.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K241611 · Imds Operations B.V. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
90d
Days
Class 2
Risk

K241611 is an FDA 510(k) clearance for the ShapeIT (SI014135). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Imds Operations B.V. (Roden, NL). The FDA issued a Cleared decision on September 3, 2024 after a review of 90 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 Imds Operations B.V. devices

FDA 510(k) Submission Details - K241611

510(k) Number K241611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2024
Decision Date September 03, 2024
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K241611.
SSPC NXT Delivery Catheter
K243180 · CenterPoint Systems, LLC · Dec 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
K242276 · Vantis Vascular, Inc. · Sep 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787 · Biotronik, Inc. · Sep 2024
TriClip Steerable Guide Catheter
K241538 · Abbott Medical · Aug 2024
Cordis BRITECROSS Support Catheter
K233637 · Cordis US Corp · Jun 2024
ASAHI Veloute
K241158 · Asahi Intecc Co., Ltd. · Jun 2024