The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath Picc (peripherally Inserted Central Catheter).
| Device ID | K983916 |
| 510k Number | K983916 |
| Device Name: | V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | James S Abilla |
| Correspondent | James S Abilla HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-03 |
| Decision Date | 1998-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3395081625 | K983916 | 000 |
| B339307616085 | K983916 | 000 |
| B339304316085 | K983916 | 000 |
| B33930291625 | K983916 | 000 |
| B33920964005 | K983916 | 000 |
| B339197616085 | K983916 | 000 |
| B339197616065 | K983916 | 000 |
| B339194316085 | K983916 | 000 |
| B339194316065 | K983916 | 000 |
| B339194616085 | K983916 | 000 |
| B3393081620 | K983916 | 000 |
| B339350255 | K983916 | 000 |
| B339360255 | K983916 | 000 |
| B33950291625 | K983916 | 000 |
| B3394081625 | K983916 | 000 |
| B339407616085 | K983916 | 000 |
| B339404316085 | K983916 | 000 |
| B33940291625 | K983916 | 000 |
| B339390255 | K983916 | 000 |
| B339380785 | K983916 | 000 |
| B339380255 | K983916 | 000 |
| B339360785 | K983916 | 000 |
| B339194616065 | K983916 | 000 |