Definition: For Use As An Access Device Accessory On Arteriovenous Fistulas (AVF) For Hemodialysis Procedures Using A Constant Site Or Buttonhole Method Of Needle Insertion.
| Device Type ID | 2091 |
| Device Name | Venous Window Needle Guide |
| Physical State | It Is Comprised Of A Port Or Septum That Permits Passage Of A Needle. |
| Technical Method | Implanted And Attached To A Vessel, Permitting Guide For Insertion Of A Needle Into The Vessel. |
| Target Area | Blood Vessel |
| Regulation Description | Blood Access Device And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2091 |
| Device | Venous Window Needle Guide |
| Product Code | PFH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Access Device And Accessories. |
| CFR Regulation Number | 876.5540 [🔎] |
| Device Problems | |
|---|---|
Insufficient Flow Or Under Infusion | 1 |
Filling Problem | 1 |
Device Operates Differently Than Expected | 1 |
Gradient Increase | 1 |
Obstruction Of Flow | 1 |
No Flow | 1 |
| Total Device Problems | 6 |