Angestat(R) Pericardial Drainage Sheath Set
FDA 510(k) K925533 · Angeion Corp.
510(k) numberK925533
Submission
- Device name
- Angestat(R) Pericardial Drainage Sheath Set
- Applicant
- Angeion Corp.
Plymouth, MN, US - Received
- November 2, 1992
- Decision date
- January 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921757 | Angeion Igital AngeflatorMAV · Traditional | 03/18/1993SE |
| K915719 | Angeion Endoscopic Valve SealODC · Traditional | 02/18/1992SE |
| K902377 | Angeflator(Tm)DXT · Traditional | 12/13/1990SE |
| K895580 | Y-Adapter W/Thouy BorstDYB · Traditional | 04/30/1990SE |
| K894446 | Angeion Hemostasis Valve IntroducerDYB · Traditional | 11/30/1989SE |
| K871153 | Catheter IntroducerDYB · Traditional | 06/24/1987SE |
Questions and answers
When was Angestat(R) Pericardial Drainage Sheath Set cleared by the FDA?
Angestat(R) Pericardial Drainage Sheath Set (K925533) received a 510(k) decision of Substantially Equivalent on January 12, 1993, 71 days after the submission was received.
What is the product code of K925533?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.