Who is the manufacturer of PRUITT SAFETY OCCLUSION CATHETER?

Ideas For Medicine, Inc. filed the 510(k) submission for PRUITT SAFETY OCCLUSION CATHETER (K960422).

What is the FDA product code for PRUITT SAFETY OCCLUSION CATHETER?

MJN. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for PRUITT SAFETY OCCLUSION CATHETER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PRUITT SAFETY OCCLUSION CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRUITT SAFETY OCCLUSION CATHETER

K960422 · Ideas For Medicine, Inc. · MJN · Aug 7, 1996 · Cardiovascular

Device Facts

Record ID	K960422
Device Name	PRUITT SAFETY OCCLUSION CATHETER
Applicant	Ideas For Medicine, Inc.
Product Code	MJN · Cardiovascular
Decision Date	Aug 7, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The intended use of this device is for occlusion of the internal carotid artery during endarterectomy.

Device Story

Single lumen balloon catheter; features external safety balloon inflating at 17 psi to prevent intraluminal balloon overinflation. Used in surgical setting (OR) by vascular surgeons during carotid endarterectomy. Provides vessel occlusion as alternative to mechanical clamping. Benefits patient by reducing risk of balloon rupture/overinflation during procedure.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO-10993.

Technological Characteristics

Single lumen balloon catheter; external safety balloon mechanism (17 psi threshold); sterile, non-pyrogenic; materials biocompatibility tested per ISO-10993.

Indications for Use

Indicated for occlusion of the internal carotid artery during endarterectomy in patients undergoing carotid endarterectomy where the surgeon chooses not to shunt.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

Pruitt Inahara Shunt

Related Devices

K960715 — PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F · Ideas For Medicine, Inc. · Sep 9, 1996
K043023 — PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 · LeMaitre Vascular, Inc. · Dec 3, 2004
K021210 — ARTERIA OCCLUSION BALLOON · Arteria Medical Science, Inc. · Oct 28, 2002
K051137 — TECHDEVICE OCCLUSION BALLOON CATHETER · Techdevice Corporation · Feb 24, 2006
K983802 — LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB · Lucas Medical, Inc. · Jul 30, 1999

Submission Summary (Full Text)

{0} AUG - 7 1996 K960422 Ideas for Medicine, Inc. Pruitt Safety Occlusion Catheter 510(k) Notification # SAFETY and EFFECTIVENESS SUMMARY ## PROPRIETARY NAME: Pruitt Safety Occlusion Catheter ## COMMON USUAL NAME: Vascular Catheter ## CLASSIFICATION: Class II ## CLASSIFICATION NUMBER: 74.DXG ## DEVICE DESCRIPTION: The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. (1) Every lot is supplied sterile and non-pyrogenic. ## SUBSTANTIAL EQUIVALENT: The intended use of this device is for occlusion of the internal carotid artery during endarterectomy. The Pruitt Inahara Shunt is a balloon shunt that provides a temporary bypass during carotid endarterectomy and features the external safety balloon. The Pruitt Occlusion Catheter provides vessel occlusion without shunting. The Pruitt Safety Occlusion Catheter combines the 2 devices and provides an alternative to clamping during carotid endarterectomy where the surgeon chooses not to shunt. 1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Device, Part I, Evaluation and Testing" for Devices in Contact with Blood (short term duration). 5