Cleared Traditional

K951448 - GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE (FDA 510(k) Clearance)

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

K951448 · Global Medical Products, Ltd. · Cardiovascular device
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Mar 1996
Decision
364d
Days
Class 2
Risk

K951448 is an FDA 510(k) clearance for the GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGE.... Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Global Medical Products, Ltd. (Road Town, Tortola, VG). The FDA issued a Cleared decision on March 27, 1996 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 Global Medical Products, Ltd. devices

Submission Details

510(k) Number K951448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1995
Decision Date March 27, 1996
Days to Decision 364 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 125d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 50
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