Cleared Special

K051096 - APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582

K051096 is an FDA 510(k) clearance for APEEL CS PLUS CATHETER DELIVERY SYSTEM, manufactured by St. Jude Medical, Daig Division, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 18-day FDA review.

K051096 · St. Jude Medical, Daig Division, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
18d
Days
Class 2
Risk

K051096 is an FDA 510(k) clearance for the APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by St. Jude Medical, Daig Division, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 17, 2005 after a review of 18 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 - K051096

510(k) Number K051096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date May 17, 2005
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
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 Peers - DYB Introducer, Catheter

All 695
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K051096.
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
K051515 · Acumen Medical, Inc. · Sep 2005
INNER-LOCK INTRODUCER SHEATH
K051468 · Rex Medical · Aug 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
PREMERE DELIVERY SHEATH, MODEL PDS
K043084 · Velocimed, Inc. · May 2005
SECURELOC
K050023 · Specialized Health Products, Inc. · Feb 2005
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018
K042308 · Facile Medical, Inc. · Feb 2005
K051096 · APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
Download PDF FDA Summary St. Jude Medical, Dai…