Who is the manufacturer of VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE?

Ideas For Medicine, Inc. filed the 510(k) submission for VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (K961716).

What is the FDA product code for VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE?

DXE. It is classified under 21 CFR 870.5150 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE?

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

What are the predicate devices for VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE?

Fogarty Embolectomy Catheter; Robicsek Angiography Embolectomy Catheters.

Who can help prepare an FDA 510(k) submission like VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE?

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.

VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE

K961716 · Ideas For Medicine, Inc. · DXE · Sep 19, 1996 · Cardiovascular

Device Facts

Record ID	K961716
Device Name	VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
Applicant	Ideas For Medicine, Inc.
Product Code	DXE · Cardiovascular
Decision Date	Sep 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

Device Story

Single lumen nylon tube with distal natural latex balloon and proximal stopcock; packaged with syringe. Available in 5 French sizes and 3 lengths. Operated by physicians in clinical settings. Procedure: catheter advanced beyond clot with balloon deflated; balloon inflated with sterile solution; catheter withdrawn to extract embolism. Benefits: mechanical removal of arterial obstructions.

Clinical Evidence

Bench testing only; materials certified to USP Class VI requirements.

Technological Characteristics

Single lumen nylon tube; natural latex balloon; proximal stopcock. Materials meet USP Class VI standards; suture meets USP grade. Sterile and non-pyrogenic. Mechanical operation via manual inflation/withdrawal.

Indications for Use

Indicated for patients requiring removal of arterial emboli and thrombi during embolectomy and thrombectomy procedures.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

Fogarty Embolectomy Catheter
Robicsek Angiography Embolectomy Catheters

Related Devices

K973477 — BIOSENSORS EMBOLECTOMY CATHETER · Sunscope Intl., Inc. · Sep 4, 1998
K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. · J-Lloyd Medical, Inc. · Feb 13, 1998
K972572 — SINGLE LUMEN EMBOLECTOMY CATHETER · American Biomed, Inc. · Jan 13, 1998
K961883 — VERSA-CATH ARTERIAL CATHETER · Ideas For Medicine, Inc. · Jan 13, 1997
K970762 — DUAL LUMEN EMBOLECTOMY CATHETER · Applied Medical Resources · Mar 28, 1997

Submission Summary (Full Text)

{0} K961716 Ideas for Medicine, Inc. Vaso-Safe Arterial Embolectomy Catheter 510(k) Notification # SAFETY and EFFECTIVENESS SUMMARY **PROPRIETARY NAME:** SEP 19 1996 Vaso-Safe Arterial Embolectomy Catheter **COMMON USUAL NAME:** Embolectomy Catheter **CLASSIFICATION:** Class II **CLASSIFICATION NUMBER:** 74 DXE **DEVICE DESCRIPTION:** The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths. The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy. The catheter, with the balloon deflated, is advanced into the vessel beyond the clot. The balloon is inflated with sterile solution. The catheter is withdrawn pulling the embolism with it, thus removing it from the artery. The materials used on the Vaso-Safe Arterial Embolectomy Catheters have been used for years on other models of Ideas for Medicine, Inc. catheters except the suture, which has been certified to USP grade. Other catheter materials have been certified to meet the requirements of USP Class VI tests. Every lot is supplied sterile and non-pyrogenic. **SUBSTANTIAL EQUIVALENCE:** The intended use of these devices is to remove arterial emboli and thrombi. This use is identical to the Fogarty Embolectomy Catheter. The Robicsek Angiography Embolectomy Catheters are for arterial emboli and thrombi removal but provide the ability to irrigate concurrent with removal. 6