Intestoplant
FDA 510(k) K862412 · Burron Medical Products, Inc.
510(k) numberK862412
Submission
- Device name
- Intestoplant
- Applicant
- Burron Medical Products, Inc.
Bethlehem, PA, US - Received
- June 25, 1986
- Decision date
- November 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLD – Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LLD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880072 | Port-A-Cath Implantable Drug Delivery SystemLLD · Traditional | Pharmacia Deltec, Inc. | 03/29/1988SE |
| K864552 | Port-A-Cath Implantable Catheter SystemLLD · Traditional | Pharmacia, Inc. | 03/31/1987SE |
| K832906 | Port-A-Cath Implantable Catheter SysLLD · Traditional | Pharmacia, Inc. | 03/06/1984SE |
More from Pharmacia, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870403 | Cavafix(R) Central Venous Catheter Kit W/SutureFOZ · Traditional | 05/01/1987SE |
| K861479 | Cavafix, Central Venous Catheter KitFOZ · Traditional | 07/01/1986SESD |
| K860126 | Stimuplex, Nerve StimulatorBXN · Traditional | 02/28/1986SE |
| K851293 | ImplantofixLJT · Traditional | 01/09/1986SE |
| K841428 | Jejunostomy Set for Tube FeedingKNT · Traditional | 07/09/1984SE |
| K834383 | Dual-Lumen Long Term Central Venous CatLJS · Traditional | 05/01/1984SE |
| K834299 | Long Term Central Venous Access CathLJS · Traditional | 05/01/1984SE |
| K834473 | Multi-Lumen Central Venous Cath. KitLJS · Traditional | 04/30/1984SE |
| K840179 | Continuous Epidural Anesthes. TrayCAZ · Traditional | 02/24/1984SE |
| K840287 | Brachial Plexus Anesthesia TrayCAZ · Traditional | 02/23/1984SE |
Questions and answers
When was Intestoplant cleared by the FDA?
Intestoplant (K862412) received a 510(k) decision of Substantially Equivalent on November 13, 1986, 141 days after the submission was received.
What is the product code of K862412?
The FDA product code is LLD – Port & Catheter, Implanted, Subcutaneous, Intraperitoneal, a Class II (moderate risk) device regulated under 21 CFR 880.5965.