What is the FDA product code for PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F?

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-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F?

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

What are the predicate devices for PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F?

Pruitt-Inahara Shunts (9 French).

Who can help prepare an FDA 510(k) submission like PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F?

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-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F

Q: Who is the manufacturer of PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F?

Ideas For Medicine, Inc. filed the 510(k) submission for PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F (K960715).

K960715 · Ideas For Medicine, Inc. · MJN · Sep 9, 1996 · Cardiovascular

Device Facts

Record ID	K960715
Device Name	PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
Applicant	Ideas For Medicine, Inc.
Product Code	MJN · Cardiovascular
Decision Date	Sep 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The intended use of these devices is to provide a temporary bypass during carotid endarterectomy.

Device Story

Dual lumen balloon shunts; channel/divert blood in carotid artery during endarterectomy. Features: T-port for patency confirmation/back-bleeding; external safety balloon on inflation port. Safety balloon inflates at 17 psi to prevent overinflation of internal carotid balloon; reduces vessel damage risk. Used in clinical setting by surgeons. Provides temporary bypass; allows procedure in smaller arteries.

Clinical Evidence

No clinical data; bench testing only. Materials certified to meet USP Class VI biocompatibility requirements.

Technological Characteristics

Dual lumen balloon catheter; 8 French diameter. Materials identical to predicate models; USP Class VI biocompatible. Mechanical safety balloon inflation mechanism (17 psi limit). Supplied sterile and non-pyrogenic.

Indications for Use

Indicated for patients undergoing carotid endarterectomy requiring temporary blood flow diversion in carotid arteries too small to accommodate a 9 French shunt.

Regulatory Classification

Identification

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

Predicate Devices

Pruitt-Inahara Shunts (9 French)

Related Devices

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
K960422 — PRUITT SAFETY OCCLUSION CATHETER · Ideas For Medicine, Inc. · Aug 7, 1996
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
K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr · Lemaitre Vascular · Nov 16, 2018
K051067 — PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) · LeMaitre Vascular, Inc. · May 27, 2005

Submission Summary (Full Text)

{0} Ideas for Medicine, Inc. Pruitt-Inahara Carotid Shunt (Model 400-40-8F) Inahara-Pruitt Carotid Shunt (Model 500-50-8F) 510(k) Notification # SAFETY and EFFECTIVENESS SUMMARY K960715 ## PROPRIETARY NAME: Pruitt-Inahara Carotid Shunt and Inahara-Pruitt Carotid Shunt SEP - 9 1996 ## COMMON USUAL NAME: Vascular Balloon Catheter ## CLASSIFICATION: Class II ## CLASSIFICATION NUMBER: Unknown ## DEVICE DESCRIPTION: The Pruitt-Inahara Carotid Shunt (Model 400-40-8F) and the Inahara-Pruitt Carotid Shunt (Model 500-50-8F) are dual lumen balloon shunts which channel and divert blood in the carotid artery during endarterectomy. The 8 French shunts are for use in arteries too small to accommodate a 9 French shunt. Both the 400-40-8F and 500-50-8F have a T Port to confirm patency and allow back-bleeding after insertion. There is an external safety balloon on the inflation port for the balloon which lies in the internal carotid artery. The safety balloon is designed to inflate when the internal carotid balloon reaches 17 psi; this reduces the possibility of balloon overinflation and resultant vessel damage. All the materials are identical to those used in other models of Ideas for Medicine’s shunts. These materials have been used for years and were certified to meet the requirements of the USP Class VI testing for biocompatibility. Every lot is supplied sterile and non-pyrogenic. ## SUBSTANTIAL EQUIVALENT: The intended use of these devices is to provide a temporary bypass during carotid endarterectomy. The 8 French Pruitt Shunts are identical in both materials and intended use to the 9 French Pruitt-Inahara Shunts. The smaller OD of the shaft will allow it to be used in smaller arteries.