Polystan Verticlude Blood Pump
FDA 510(k) K813035 · Advocacy International, Ltd.
510(k) numberK813035
Submission
- Device name
- Polystan Verticlude Blood Pump
- Applicant
- Advocacy International, Ltd.
Walker, MI, US - Received
- October 28, 1981
- Decision date
- November 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4370
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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|---|---|---|---|
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| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 3M Health Care, Sarns | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
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Questions and answers
When was Polystan Verticlude Blood Pump cleared by the FDA?
Polystan Verticlude Blood Pump (K813035) received a 510(k) decision of Substantially Equivalent on November 27, 1981, 30 days after the submission was received.
What is the product code of K813035?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.