The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Arterial Embolectomy.
Device ID | K935405 |
510k Number | K935405 |
Device Name: | ARTERIAL EMBOLECTOMY |
Classification | Catheter, Embolectomy |
Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
Contact | James L Skaggs, Sr |
Correspondent | James L Skaggs, Sr J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-09 |
Decision Date | 1994-07-25 |