The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Puncture Kit, Internal Jugular.
| Device ID | K770462 |
| 510k Number | K770462 |
| Device Name: | PUNCTURE KIT, INTERNAL JUGULAR |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-09 |
| Decision Date | 1977-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902097973 | K770462 | 000 |
| 30801902067372 | K770462 | 000 |
| 10801902097979 | K770462 | 000 |
| 20801902148128 | K770462 | 000 |
| 20801902146810 | K770462 | 000 |
| 20801902067375 | K770462 | 000 |