The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Jugular Puncture Kit 16 Ga..
Device ID | K820009 |
510k Number | K820009 |
Device Name: | ARROW JUGULAR PUNCTURE KIT 16 GA. |
Classification | Catheter, Percutaneous |
Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Correspondent | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-05 |
Decision Date | 1982-01-22 |