Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath.
FDA 510(k) K882289 · Aries Medical, Inc.
510(k) numberK882289
Submission
- Device name
- Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath.
- Applicant
- Aries Medical, Inc.
Woburn, MA, US - Received
- June 1, 1988
- Decision date
- December 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular GraftDSY · Traditional | Maquet Cardiovascular, LLC | 04/27/2026SE |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional | Vascular Flow Technologies Limited | 10/20/2025SE |
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 11/15/2024SE |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | Atrium Medical Corporation | 03/28/2024SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 03/01/2024SE |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional | Peca Labs, Inc. | 01/17/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | W. L. Gore & Associates, Inc. | 06/23/2023SE |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912604 | Sjm/Cad Isoflow(Tm) Centrifugal Pump 2100CP, ModifKFM · Traditional | 10/28/1991SE |
| K903925 | Aries Meldical Model 2100HC Hank CrankKFM · Traditional | 12/21/1990SE |
| K903442 | Aries Taperseal(Tm) SheathDYB · Traditional | 08/23/1990SE |
| K895433 | Aries 30CC & 50CC Intra-Aortic Balloon & Cont. SysDSP · Traditional | 04/10/1990SE |
| K864994 | 40CC Per. Pre-Furl (S/L) Intra-Aortic CatheterDSP · Traditional | 06/19/1987SE |
| K864537 | 40CC Percutaneous Pre-Furl (D/L) Balloon CatheterDSP · Traditional | 06/19/1987SE |
| K864568 | 40CC Surgical Double Lumen Balloon CatheterDSP · Traditional | 05/12/1987SE |
| K864567 | 40CC Percutaneous Furl Dou. Lumen Balloon CatheterDSP · Traditional | 05/12/1987SE |
| K871140 | Aries Peel Away Percutaneous Catheter IntroducerDYB · Traditional | 04/22/1987SE |
| K870189 | Aries Tapered SheathDYB · Traditional | 03/16/1987SE |
Questions and answers
When was Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath. cleared by the FDA?
Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath. (K882289) received a 510(k) decision of Substantially Equivalent on December 12, 1988, 194 days after the submission was received.
What is the product code of K882289?
The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.