The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Modification To: Latex-free Bionector, Model# 896.019, 896.039.
| Device ID | K070705 |
| 510k Number | K070705 |
| Device Name: | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-14 |
| Decision Date | 2007-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884001908 | K070705 | 000 |
| 38498840006512 | K070705 | 000 |
| 30849884006200 | K070705 | 000 |