Cleared Traditional

Guiding Catheter (K210009) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210009 · CenterPoint Systems, LLC · Cardiovascular device
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Nov 2021
Decision
324d
Days
Class 2
Risk

K210009 is an FDA 510(k) clearance for the Guiding Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on November 24, 2021 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 CenterPoint Systems, LLC devices

Submission Details

510(k) Number K210009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2021
Decision Date November 24, 2021
Days to Decision 324 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
199d slower than avg
Panel avg: 125d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 316
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K210009.
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K210322 · Transit Scientific, LLC · Oct 2021
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K212026 · Abbott Medical · Sep 2021
Amplatzer Talisman Delivery Sheath
K212738 · Abbott Medical · Sep 2021