Cleared Special

K161102 - Nanostim Introducer Kit

K161102 is an FDA 510(k) clearance for Nanostim Introducer Kit, manufactured by St. Jude Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 30-day FDA review.

K161102 · St. Jude Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
30d
Days
Class 2
Risk

K161102 is an FDA 510(k) clearance for the Nanostim Introducer Kit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St. Jude Medical, Inc. (Sylmar, US). The FDA issued a Cleared decision on May 19, 2016 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161102

510(k) Number K161102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2016
Decision Date May 19, 2016
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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

St Jude Medical
Hassan Labay

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 - DYB Introducer, Catheter

All 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K161102.
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · Libramedical, Inc. · Jul 2016
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
K153533 · Galt Medical Corp. · Jul 2016
Halo One Thin-Walled Guiding Sheath
K161183 · C.R. Bard, Inc. · Jun 2016
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016
The Nanostim Introducer Kit
K160716 · St. Jude Medical, Inc. · Apr 2016
transGlide Expandable Introducer
K152194 · Transaortic Medical, Inc. · Apr 2016