Cleared Traditional

K951448 - GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE

K951448 is an FDA 510(k) clearance for GLOBAL MEDICAL PRODUCTS POTTS COURNAND, manufactured by Global Medical Products, Ltd.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K951448 · Global Medical Products, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K951448

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
Combination Product No
PCCP Authorized No
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.

DRC Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K951448.
MANAN GWI GUIDE WIRE INTRODUCER
K974745 · Medical Device Technologies, Inc. · Apr 1998
HEARTPORT THORACIC TROCAR
K964302 · Heartport, Inc. · May 1997
HEARTPORT NEEDLE TROCAR
K965051 · Heartport, Inc. · Mar 1997
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · Arrow Intl., Inc. · Mar 1993
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · E-Z-Em, Inc. · Dec 1991
LAPAROSCOPIC TROCAR
K911483 · United States Endoscopy Group, Inc. · Jul 1991