Cleared Traditional

K072278 - BRK TRANSSEPTAL NEEDLE

K072278 is an FDA 510(k) clearance for BRK TRANSSEPTAL NEEDLE, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K072278 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
28d
Days
Class 2
Risk

K072278 is an FDA 510(k) clearance for the BRK TRANSSEPTAL NEEDLE. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on September 13, 2007 after a review of 28 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 St Jude Medical devices

FDA 510(k) Submission Details - K072278

510(k) Number K072278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date September 13, 2007
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRC Trocar

All 41
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K072278.
MOBICATH TRANSSEPTAL NEEDLE
K122832 · Great Batch Medical · Dec 2012
MOBICATH TRANSSEPTAL NEEDLE
K111644 · Great Batch Medical · Oct 2011
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · Oscor, Inc. · Nov 2008
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
TRANSSEPTAL NEEDLE/TROCAR
K011727 · Thomas Medical Products, Inc. · May 2002