Cleared Traditional

K011727 - TRANSSEPTAL NEEDLE/TROCAR

K011727 is an FDA 510(k) clearance for TRANSSEPTAL NEEDLE/TROCAR, manufactured by Thomas Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K011727 · Thomas Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
332d
Days
Class 2
Risk

K011727 is an FDA 510(k) clearance for the TRANSSEPTAL NEEDLE/TROCAR. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on May 2, 2002 after a review of 332 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.

FDA 510(k) Submission Details - K011727

510(k) Number K011727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date May 02, 2002
Days to Decision 332 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
207d slower than avg
Panel avg: 125d · This submission: 332d
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 50
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K011727.
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
K061070 · Hansen Medical, Inc. · Oct 2006
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117 · Merit Medical Systems, Inc. · Oct 2002
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
K022257 · Vomed Volzer Medizintechnik GmbH & Co. · Oct 2002
INSTRUMENT DAMPING PORT
K011373 · Medcanica, Inc. · Oct 2001
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
K011349 · Medcanica, Inc. · Oct 2001
MANAN POTTS-COURNAND NEEDLE
K974742 · Medical Device Technologies, Inc. · Apr 1998
K011727 · TRANSSEPTAL NEEDLE/TROCAR
Download PDF FDA Summary Thomas Medical Produc…