The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Premicath, 1261.205.
| Device ID | K041468 |
| 510k Number | K041468 |
| Device Name: | PREMICATH, 1261.205 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-02 |
| Decision Date | 2004-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002356 | K041468 | 000 |
| 38498840011165 | K041468 | 000 |
| 38498840011158 | K041468 | 000 |
| 38498840011141 | K041468 | 000 |
| 38498840009537 | K041468 | 000 |
| 38498840008523 | K041468 | 000 |
| 38498840008509 | K041468 | 000 |
| 38498840008493 | K041468 | 000 |
| 38498840008486 | K041468 | 000 |
| 38498840011172 | K041468 | 000 |
| 38498840011189 | K041468 | 000 |
| 30849884002349 | K041468 | 000 |
| 30849884002318 | K041468 | 000 |
| 30849884002301 | K041468 | 000 |
| 30849884002295 | K041468 | 000 |
| 30849884002288 | K041468 | 000 |
| 30849884002271 | K041468 | 000 |
| 30849884001168 | K041468 | 000 |
| 38498840011196 | K041468 | 000 |
| 38498840008479 | K041468 | 000 |