The following data is part of a premarket notification filed by Arrow International, Llc (a Subsidiary Of Teleflex, Inc.) with the FDA for Vps Rhythm Dlx Device With Tiptracker Technology.
| Device ID | K220363 |
| 510k Number | K220363 |
| Device Name: | VPS Rhythm DLX Device With TipTracker Technology |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Arrow International, LLC (a Subsidiary Of Teleflex, Inc.) 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Elizabeth Duncan |
| Correspondent | Elizabeth Duncan Arrow International, LLC (a Subsidiary Of Teleflex, Inc.) 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902208709 | K220363 | 000 |
| 10801902211917 | K220363 | 000 |
| 20801902208716 | K220363 | 000 |
| 20801902208747 | K220363 | 000 |
| 20801902208778 | K220363 | 000 |
| 20801902209348 | K220363 | 000 |
| 20801902208723 | K220363 | 000 |
| 20801902208730 | K220363 | 000 |
| 20801902208754 | K220363 | 000 |
| 20801902208761 | K220363 | 000 |
| 20801902208693 | K220363 | 000 |
| 20801902209362 | K220363 | 000 |