← Product Code [MAV](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV) · K953522

# USCI IDEAL PTCA KIT (K953522)

_Ryder Intl. Corp. · MAV · Apr 17, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K953522

## Device Facts

- **Applicant:** Ryder Intl. Corp.
- **Product Code:** [MAV](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV.md)
- **Decision Date:** Apr 17, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1650
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.

## Device Story

Ryder Balloon Catheter Inflation Syringe; manual screw-type plunger mechanism with locking lever and rotating palm grip; 20 cc fluid capacity; operating pressure range vacuum to 30 bars; includes manometer for pressure monitoring and high-pressure connecting tube; used by clinicians during angioplasty; provides controlled inflation/deflation of balloon catheters; enables precise pressure management; single-use device.

## Clinical Evidence

Bench testing only; USP material biocompatibility testing performed on patient-contacting components.

## Technological Characteristics

Plastic syringe construction; screw-type plunger; locking lever; rotating palm grip; integrated manometer; high-pressure connecting tube; 20 cc capacity; 0-30 bar pressure range; single-use.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Predicate Devices

- Merit Medical Systems Monarch™ Balloon Catheter Inflation Syringe

## Submission Summary (Full Text)

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1953522

# XII. SUMMARY OF SAFETY AND EFFECTIVENESS

Date of Preparation: July xx, 1995

Device Name: Ryder Balloon Catheter Inflation Syringe

Classification Name: Balloon Catheter Inflation Syringe

Manufacturer: Ryder International Corporation, 100 Curt Francis Road, Arab, AL 35016

Contact: Mr. D. Clark, Ryder International Corporation, 100 Curt Francis Road, Arab. AL 35016

Predicate: Merit Medical Systems Monarch™ Balloon Catheter Inflation Syringe

## Device Description/ Intended Use:

The Ryder Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube.

The Ryder Device has a fluid capacity of 20 cc. and an operating pressure range of vacuum to 30 bars.

The Ryder device is intended for single use inflating of a balloon catheter, monitoring the pressure within the catheter and deflating the balloon catheter during angioplasty procedures.

## Summary of Safety Testing:

The materials of the device which contact the contrast solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K953522](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MAV/K953522)

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