The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath Dual Lumen E.s.p. Peripheral Inserted Central Catheter.
| Device ID | K953300 |
| 510k Number | K953300 |
| Device Name: | V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Bruce Fields |
| Correspondent | Bruce Fields HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-14 |
| Decision Date | 1996-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3395071665 | K953300 | 000 |
| B339350005 | K953300 | 000 |
| B3393071665 | K953300 | 000 |
| B3393041665 | K953300 | 000 |
| B339302916600 | K953300 | 000 |
| B339302516605 | K953300 | 000 |
| B3393001665 | K953300 | 000 |
| B339252516505 | K953300 | 000 |
| B339194416405 | K953300 | 000 |
| B339194416255 | K953300 | 000 |
| B339194316405 | K953300 | 000 |
| B339194316255 | K953300 | 000 |
| B339194216400 | K953300 | 000 |
| B339194616405 | K953300 | 000 |
| B339194616250 | K953300 | 000 |
| B339350015 | K953300 | 000 |
| B339352516605 | K953300 | 000 |
| B339352526605 | K953300 | 000 |
| B339502926605 | K953300 | 000 |
| B339502916605 | K953300 | 000 |
| B3394071665 | K953300 | 000 |
| B339402916605 | K953300 | 000 |
| B339392926605 | K953300 | 000 |
| B339392926505 | K953300 | 000 |
| B399390765 | K953300 | 000 |
| B339385755 | K953300 | 000 |
| B339380755 | K953300 | 000 |
| B339380015 | K953300 | 000 |
| B339360015 | K953300 | 000 |
| B339355755 | K953300 | 000 |
| B339355725 | K953300 | 000 |
| B339355705 | K953300 | 000 |
| B339304316605 | K953300 | 000 |