The following data is part of a premarket notification filed by Deltec, Inc. with the FDA for Gripper Plus Needle.
| Device ID | K021999 |
| 510k Number | K021999 |
| Device Name: | GRIPPER PLUS NEEDLE |
| Classification | Set, Administration, Intravascular |
| Applicant | DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-19 |
| Decision Date | 2002-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586025659 | K021999 | 000 |
| 10610586025648 | K021999 | 000 |
| 30610586025635 | K021999 | 000 |