ClearanceBrief
Company ยท US

Apheresis Technologies, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1996. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
FIRPump, Blood, Extra-Luminal4
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 14, 1996K961137ATI PLASMA PUMP (PP-04)
Apheresis Technologies, Inc.
FIR
Mar 2, 1993K926409PLASMA DISCARD BAGS
Apheresis Technologies, Inc.
LKN

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 6, 2012Apheresis Technologies, Inc.
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Terminated
FIRK961137
May 24, 2012Apheresis Technologies, Inc.
PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.
Terminated
FIRNone listed
Aug 27, 2009Apheresis Technologies, Inc.
Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic
Terminated
FIRK961137
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