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Microcap & Penny Stocks : AMERICAN BIOMED, Minimally Invasive Technology (ABMI)
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To: Ray Tarke who wrote (1377)6/30/1998 9:16:00 PM
From: Ray Tarke  Read Replies (1) of 2887
 

REGULATORY STATUS OF PRODUCTS

As of June 22, 1998



======================================================================================================
510(K) REVENUE
PRODUCT NUMBER* FDA STATUS Y/N
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Arterial Embolectomy Catheter (3Fr - 7Fr) K881455 Approved 4/6/88 Y
------------------------------------------------------------------------------------------------------
Bi-lumen Irrigation Catheter (5Fr - 7Fr) K893680 Approved 8/1/89 Y
------------------------------------------------------------------------------------------------------
Bi-lumen Irrigation Catheter (3Fr - 4Fr) K897184 Approved 3/14/90 Y
------------------------------------------------------------------------------------------------------
Foley Urological Catheter K862124 Approved 8/14/86 N
------------------------------------------------------------------------------------------------------
Thermodilution Catheter K893435 Approved 5/2/89 Y
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Arterial Embolectomy Catheter (2Fr) K905139 Approved 2/5/91 Y
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Angioscopic/Angiographic Irrigation Catheter (6Fr - 8Fr) K897051 Approved 3/16/90 N
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Biliary Catheter K910917 Approved 8/2/91 Y
------------------------------------------------------------------------------------------------------
Occlusion Catheter K910916 Approved 6/24/91 Y
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Thrombectomy Catheter (dual balloon) K972572 Approved 1/13/98 Y
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Evert-O-Cath(TM) Catheter (drug delivery) K922455 Approved 7/7/94 N
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OmniCath(R) N/A IDE Filed** Y
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Omni Filter (Guidewire Micro Filter) N/A Development N
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OmniStent(TM) N/A Development N
------------------------------------------------------------------------------------------------------
Spinal Dissector N/A Development N
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Heart Assist Pump N/A Development N
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Needle Scope N/A Development N
====================================================================


** Investigational Device Exemption ("IDE")


Regards,
R.T

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