Harbor S.E.A.-Port Surgical Accessory Kit
FDA 510(k) K882657 · Harbor Medical Devices, Inc.
510(k) numberK882657
Submission
- Device name
- Harbor S.E.A.-Port Surgical Accessory Kit
- Applicant
- Harbor Medical Devices, Inc.
Boston, MA, US - Received
- June 29, 1988
- Decision date
- December 13, 1988
- 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 |
|---|---|---|
| K884628 | Harborin Central Venous CatheterDQR · Traditional | 05/15/1989SE |
| K890518 | Single Lumen S.E.A.-Port Vascular Access SystemLJT · Traditional | 04/21/1989SE |
| K881884 | Harbor Central Venous CatheterDQR · Traditional | 07/28/1988SE |
| K882190 | S.E.A.-Port(Tm) Vascular Access SystemLJT · Traditional | 06/09/1988SE |
| K880297 | Sea - Port Infusion SetLJT · Traditional | 02/19/1988SE |
| K874414 | Hypodermic Needles, Single LumenFMI · Traditional | 01/14/1988SE |
Questions and answers
When was Harbor S.E.A.-Port Surgical Accessory Kit cleared by the FDA?
Harbor S.E.A.-Port Surgical Accessory Kit (K882657) received a 510(k) decision of Substantially Equivalent on December 13, 1988, 167 days after the submission was received.
What is the product code of K882657?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.