Device Classification Name |
catheter, septostomy
|
510(k) Number |
K073326 |
Device Name |
NRG TRANSSEPTAL NEEDLE |
Applicant |
BAYLIS MEDICAL CO., INC. |
2645 MATHESON BLVD. E |
MISSISSAUGA, ONTARIO,
CA
L4W 5S4
|
|
Applicant Contact |
MEGHAL KHAKHAR |
Correspondent |
BAYLIS MEDICAL CO., INC. |
2645 MATHESON BLVD. E |
MISSISSAUGA, ONTARIO,
CA
L4W 5S4
|
|
Correspondent Contact |
MEGHAL KHAKHAR |
Regulation Number | 870.5175
|
Classification Product Code |
|
Date Received | 11/27/2007 |
Decision Date | 05/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|