FDA 510(k) Applications Submitted by KEVIN MACDONALD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080500 |
02/25/2008 |
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 |
ACUMEN MEDICAL, INC. |
| K010954 |
03/30/2001 |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 |
CONCENTRIC MEDICAL, INC. |
| K101252 |
05/04/2010 |
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 |
NEOTRACT, INC. |
| K021899 |
06/10/2002 |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 |
CONCENTRIC MEDICAL, INC. |
| K061700 |
06/16/2006 |
NEOTRACT ANCHOR |
NEOTRACT, INC. |
| K142164 |
08/06/2014 |
MANIPULATOR; MANIPULATOR PRO |
GYNETECH PTY. LTD. |
| K142700 |
09/22/2014 |
InsufflatOR Needle |
GYNETECH PTY. LTD. |
| K083855 |
12/24/2008 |
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 |
ACUMEN MEDICAL, INC. |
| K030476 |
02/13/2003 |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 |
CONCENTRIC MEDICAL, INC. |
| K040700 |
03/17/2004 |
CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 |
CONCENTRIC MEDICAL, INC. |
| K040745 |
03/23/2004 |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 |
CONCENTRIC MEDICAL, INC. |
| K102028 |
07/19/2010 |
NEOTRACT ANCHOR SYSTEM MODEL TAS400 |
NEOTRACT, INC. |
| K003173 |
10/10/2000 |
ASPIRE COVERED STENT AND DELIVERY CATHETER |
VASCULAR ARCHITECTS, INC. |
| K964161 |
10/17/1996 |
HEARTPORT ENDOAORTIC CLAMP |
HEARTPORT, INC. |
| K964248 |
10/24/1996 |
HEARTPORT ENDOCORONARY SINUS CATHETR |
HEARTPORT, INC. |
| K033736 |
11/28/2003 |
MERCI RETRIEVER, MODELS 90065, 90066 |
CONCENTRIC MEDICAL, INC. |
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