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Pediatric Intra-aortic Balloon Catheters

FDA 510(k)

Class II (US FDA 510(k))

510(k) K905663

by Datascope Corp.

Identifiers

510(k) Number
K905663 FDA 510(k)
FDA Product Code
DSP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3535 FDA 510(k)
Regulation Number
870.3535 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Pediatric Intra-aortic Balloon Catheters are a system, balloon, intra-aortic and control device used in cardiovascular applications. This device is classified as a Class II medical device under regulation number 870.3535.

The device received FDA 510(k) clearance (K905663) on August 2, 1993, following a traditional review process. It is manufactured by Datascope Corp. and is supplied as a non-sterile, reusable or single-use device depending on the specific model, with no MRI safety information provided in the data.

Frequently asked questions

What is the Pediatric Intra-aortic Balloon Catheter used for?

This device is used in cardiovascular applications as a system, balloon, intra-aortic and control device, classified as Class II under regulation 870.3535 for hemodynamic support in pediatric patients.

Is the Pediatric Intra-aortic Balloon Catheter sterile or non-sterile when supplied?

The device is supplied as non-sterile, meaning it requires sterilization by the user before use, as explicitly stated in the device data.

Can the Pediatric Intra-aortic Balloon Catheter be reused or is it single-use?

Depending on the specific model, the device may be either reusable or single-use, as the data indicates it is supplied as a non-sterile, reusable or single-use device based on model variation.

What regulatory pathway was used for the Pediatric Intra-aortic Balloon Catheter?

The device received FDA 510(k) clearance (K905663) on August 2, 1993, through a traditional review process, confirming its substantial equivalence to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PEDIATRIC INTRA-AORTIC BALLOON CATHETERS (K905663) — FDA 510(k ..., Pediatric Intra-aortic Balloon Catheters 510 (k) FDA Premarket ..., PDF K905663 - Pediatric Intra-aortic Balloon Catheters, Datascope Corp. | DAIC, Datascope'S 8fr. 50cc Intra-aortic Balloon Catheter and Accessories ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA 510(k) K905663 24 fields · synced Sep 25, 2026