← Product Code [DXE](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE) · K961716

# VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE (K961716)

_Ideas For Medicine, Inc. · DXE · Sep 19, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K961716

## Device Facts

- **Applicant:** Ideas For Medicine, Inc.
- **Product Code:** [DXE](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE.md)
- **Decision Date:** Sep 19, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5150
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for 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 Procedure: catheter advanced beyond clot with balloon deflated; balloon inflated with sterile solution; catheter withdrawn to extract embolism.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.

## Regulatory 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

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{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

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K961716](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXE/K961716)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com