Guidant Proximal Seal System, Models PSS-4500 & PS-4500
FDA 510(k) K022880 · Guidant Corp.
510(k) numberK022880
Submission
- Device name
- Guidant Proximal Seal System, Models PSS-4500 & PS-4500
- Applicant
- Guidant Corp.
Lafayette, CA, US - Received
- August 30, 2002
- Decision date
- September 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
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| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
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Questions and answers
When was Guidant Proximal Seal System, Models PSS-4500 & PS-4500 cleared by the FDA?
Guidant Proximal Seal System, Models PSS-4500 & PS-4500 (K022880) received a 510(k) decision of Substantially Equivalent on September 13, 2002, 14 days after the submission was received.
What is the product code of K022880?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.