Single Use Seldinger/Cournand Perc. NDL
FDA 510(k) K810859 · Procedure Products, Inc.
510(k) numberK810859
Submission
- Device name
- Single Use Seldinger/Cournand Perc. NDL
- Applicant
- Procedure Products, Inc.
Mchenry, IL, US - Received
- March 30, 1981
- Decision date
- April 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
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| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
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| K914128 | Connecting SetDQO · Traditional | 11/27/1991SE |
| K910673 | Bag SpigotKPE · Traditional | 04/24/1991SE |
| K884985 | Modified 10CC Syringe Control Ring SetFMF · Traditional | 12/20/1988SE |
| K874747 | 10CC Syringe Control Ring SetFMF · Traditional | 02/04/1988SE |
| K874037 | Angio Waste Fluids Dump BagDQO · Traditional | 01/29/1988SE |
| K853749 | Custom Coronary Manifold KitsDTL · Traditional | 01/13/1986SE |
| K842173 | Disposable StopcocksFMG · Traditional | 09/05/1984SE |
Questions and answers
When was Single Use Seldinger/Cournand Perc. NDL cleared by the FDA?
Single Use Seldinger/Cournand Perc. NDL (K810859) received a 510(k) decision of Substantially Equivalent on April 11, 1981, 12 days after the submission was received.
What is the product code of K810859?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.