A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
FDA 510(k) clearance K963684 · decided 1996-10-24
Clearance details
- K-number
- K963684
- Device name
- A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-12
- Decision date
- 1996-10-24
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| FLEXI-PORT™ Power Injectable Implantable Port (K260916) | Portal Access, Inc. | 2026-06-17 |
| Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (K252478) | Bard Access Systems, Inc. | 2025-09-05 |
| PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253) | Bard Access Systems, Inc. | 2025-06-18 |
| PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (K242328) | Bard Access Systems, Inc. | 2024-10-31 |
| PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port (K232737) | Bard Peripheral Vascular, Inc. | 2023-12-08 |
| SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (K190559) | AngioDynamics, Inc. | 2020-05-22 |
| Bard Power-Injectable Implantable Ports (PowerPorts®) (K181446) | C.R. Bard, Inc. | 2019-07-08 |
| NMI DUAL PORT II (K151239) | Navilyst Medical, Inc. | 2016-06-06 |
| BardPort®, SlimPort®, and X-Port® Implanted Ports (K153359) | C.R. Bard, Inc. | 2016-05-20 |
| Dignity Dual Port (K153238) | Medcomp ( Medical Components) | 2016-03-15 |
| NMI Port, NMI Port II (K153228) | Navilyst Medical, Inc. | 2015-12-04 |
| Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (K150514) | C.R. Bard, Inc. | 2015-11-20 |
Recalls involving this device
No recalls on record reference this clearance.