The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Embolectomy, Irrigation - Occlusion Balloon Catheter By J-lloyd Medical, Inc..
| Device ID | K974335 |
| 510k Number | K974335 |
| Device Name: | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. |
| 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 | 1997-11-18 |
| Decision Date | 1998-02-13 |
| Summary: | summary |