Aci Pulsating Vacuum Pump System

FDA 510(k) K954286 · Advanced Cytometrix, Inc.

Substantially Equivalent

510(k) numberK954286

Submission

Device name
Aci Pulsating Vacuum Pump System
Applicant
Advanced Cytometrix, Inc.
Sunnyvale, CA, US
Received
September 14, 1995
Decision date
November 29, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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More from Shenzhen Kingboom Technology Co., Ltd.

510(k)DeviceDecision
K954287Aci Fine Needle Aspiration Biopsy KitBTA · Traditional 11/29/1995SE
K954264Aci Single Lumen Biopsy NeedleBTA · Traditional 11/29/1995SE

Questions and answers

When was Aci Pulsating Vacuum Pump System cleared by the FDA?

Aci Pulsating Vacuum Pump System (K954286) received a 510(k) decision of Substantially Equivalent on November 29, 1995, 76 days after the submission was received.

What is the product code of K954286?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.