The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath Poly Picc.
| Device ID | K071875 |
| 510k Number | K071875 |
| Device Name: | V-CATH POLY PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | HDC CORP. 628 GIBRALTAR CT. Milpitas, CA 95035 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 628 GIBRALTAR CT. Milpitas, CA 95035 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2007-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B339509226605 | K071875 | 000 |
| B3393010116105 | K071875 | 000 |
| B3393010116185 | K071875 | 000 |
| B3393012116185 | K071875 | 000 |
| B339309116405 | K071875 | 000 |
| B3394010116085 | K071875 | 000 |
| B3394010116105 | K071875 | 000 |
| B3394010116185 | K071875 | 000 |
| B3394012116185 | K071875 | 000 |
| B339409116605 | K071875 | 000 |
| B339409216605 | K071875 | 000 |
| B339509126600 | K071875 | 000 |
| B3393010116085 | K071875 | 000 |