TidalPort-AP Implantable Apheresis Vascular Access Port
K192291 is the FDA 510(k) clearance record for TidalPort-AP Implantable Apheresis Vascular Access Port, a class II device, cleared for Norfolk Medical Products, Inc. on under FDA product code PTD (Subcutaneous Implanted Apheresis Port). FDA's definition for product code PTD reads: "A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis". FDA records list 20 510(k) clearances for Norfolk Medical Products, Inc., from to . As of , FDA records show no recalls naming K192291.
Clearance record
- Decision date
- Received
- (363 days to decision)
- Product code
- PTD Subcutaneous Implanted Apheresis Port
- Regulation
- 21 CFR 880.5965
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- Norfolk Medical Products, Inc. 7350 N. Ridgeway Ave., Skokie IL
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code PTD
Trailing 12 monthsFDA records hold no clearances under product code PTD in the trailing twelve months.
Show the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
