Percutaneous Entry Needle, Seldinger
FDA 510(k) K813461 · Ocean Medical Products, Ltd.
510(k) numberK813461
Submission
- Device name
- Percutaneous Entry Needle, Seldinger
- Applicant
- Ocean Medical Products, Ltd.
Mchenry, IL, US - Received
- December 11, 1981
- Decision date
- December 29, 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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| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| 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 |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K882013 | Soft Tissue Biopsy DeviceDWO · Traditional | 06/15/1988SE |
| K870896 | Notch-Needle, Wescott StyleGAA · Traditional | 03/18/1987SE |
| K843719 | Single Wall Introducer NeedleDYB · Traditional | 10/18/1984SE |
| K823693 | Myelography NeedleFMI · Traditional | 02/07/1983SE |
| K823692 | Spinal NeedleBSP · Traditional | 01/07/1983SE |
| K813462 | Madayag Type NeedleKNW · Traditional | 03/01/1982SE |
| K813460 | Chiba Skinny NeedleGAA · Traditional | 01/07/1982SE |
| K813448 | Potts-Cournand Style NeedleGAA · Traditional | 01/07/1982SE |
Questions and answers
When was Percutaneous Entry Needle, Seldinger cleared by the FDA?
Percutaneous Entry Needle, Seldinger (K813461) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 18 days after the submission was received.
What is the product code of K813461?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.