Single Wall Introducer Needle
FDA 510(k) K843719 · Ocean Medical Products, Ltd.
510(k) numberK843719
Submission
- Device name
- Single Wall Introducer Needle
- Applicant
- Ocean Medical Products, Ltd.
Wyoming, MI, US - Received
- September 24, 1984
- Decision date
- October 18, 1984
- 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 |
|---|---|---|
| K882013 | Soft Tissue Biopsy DeviceDWO · Traditional | 06/15/1988SE |
| K870896 | Notch-Needle, Wescott StyleGAA · Traditional | 03/18/1987SE |
| 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 |
| K813461 | Percutaneous Entry Needle, SeldingerDRE · Traditional | 12/29/1981SE |
Questions and answers
When was Single Wall Introducer Needle cleared by the FDA?
Single Wall Introducer Needle (K843719) received a 510(k) decision of Substantially Equivalent on October 18, 1984, 24 days after the submission was received.
What is the product code of K843719?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.