The following data is part of a premarket notification filed by Pilling Co. with the FDA for Jehle Coronary Perfusion Catheters.
| Device ID | K884946 |
| 510k Number | K884946 |
| Device Name: | JEHLE CORONARY PERFUSION CATHETERS |
| Classification | Catheter, Continuous Flush |
| Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Leland J Wimer |
| Correspondent | Leland J Wimer PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-28 |
| Decision Date | 1989-02-06 |