Cleared Traditional

K895455 - SELDINGER PERCUTANEOUS 2 PC NEEDLES

K895455 is the FDA 510(k) clearance for SELDINGER PERCUTANEOUS 2 PC NEEDLES by Advance Medical Designs, Inc.. It is a Class 2 Cardiovascular device (product code DRC) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K895455 · Advance Medical Designs, Inc. · Cardiovascular device
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Nov 1989
Decision
70d
Days
Class 2
Risk

K895455 is an FDA 510(k) clearance for the SELDINGER PERCUTANEOUS 2 PC NEEDLES. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K895455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date November 14, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 25
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K895455.
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
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707 · United States Surgical, A Division of Tyco Healthc · Jun 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209 · E-Z-Em, Inc. · May 1989
MEDSURG POTT-COURNAND NEEDLE
K854293 · Medsurg Industries, Inc. · Jan 1986