FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K960169

Device Name

CARBOMEDICS VALVE TESTER

Manufacturer

CARBOMEDICS, INC.

Date Cleared

1996-04-15

(90 days)

Product Code

DTJ

Regulation Number

870.3935

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 870.3935 Prosthetic heart valve holder.

(a)
Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Summary

N/A