Aries Peel Away Percutaneous Catheter Introducer
FDA 510(k) K871140 · Aries Medical, Inc.
510(k) numberK871140
Submission
- Device name
- Aries Peel Away Percutaneous Catheter Introducer
- Applicant
- Aries Medical, Inc.
North Attleboro, MA, US - Received
- March 23, 1987
- Decision date
- April 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, 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 |
| K882289 | Aries 40CC Percu. (D/L) Intra-Aortic Balloon Cath.DSY · Traditional | 12/12/1988SE |
| 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 |
| K870189 | Aries Tapered SheathDYB · Traditional | 03/16/1987SE |
Questions and answers
When was Aries Peel Away Percutaneous Catheter Introducer cleared by the FDA?
Aries Peel Away Percutaneous Catheter Introducer (K871140) received a 510(k) decision of Substantially Equivalent on April 22, 1987, 30 days after the submission was received.
What is the product code of K871140?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.