Haemonetics 600 Ml. Component Bag
FDA 510(k) K810711 · Haemonetics Corp.
510(k) numberK810711
Submission
- Device name
- Haemonetics 600 Ml. Component Bag
- Applicant
- Haemonetics Corp.
Mchenry, IL, US - Received
- March 17, 1981
- Decision date
- May 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSR – Container, Empty, For Collection & Processing Of Blood & Blood Components
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9100
- Specialty
- Hematology
Other 510(k)s with product code KSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032827 | Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501KSR · Traditional | Tyco Healthcare | 12/08/2003SE |
| K020753 | Deroyal Surgical, UmbilicupKSR · Traditional | Deroyal | 06/13/2002SE |
| K810897 | Alpha Plastic Plasma BottleKSR · Traditional | Alpha Therapeutic Corp. | 09/23/1981SE |
| K810500 | Blood Freezing BagKSR · Traditional | Delmed, Inc. | 09/23/1981SE |
| K811523 | Plasma FlexKSR · Traditional | Terumo America, Inc. | 09/09/1981SE |
| K811449 | Haemonetics 1000ML Component BagKSR · Traditional | Haemonetics Corp. | 07/01/1981SE |
| K810313 | Haemonetics 1400 ML Therapeutic BagKSR · Traditional | Haemonetics Corp. | 03/31/1981SE |
| K801219 | PlasmapoolerKSR · Traditional | North American Biologicals, Inc. | 10/31/1980SE |
| K801082 | Gambro Hemofreeze-BagKSR · Traditional | Gambro, Inc. | 10/31/1980SE |
| K792395 | Pharmaflex Cryogenic BagKSR · Traditional | Pharmachem Corp. | 02/26/1980SE |
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| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | 03/29/2024SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | 11/15/2022SE |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA · Traditional | 05/09/2019SE |
| K160502 | TEG 6s Hemostasis SystemJPA · Special | 04/19/2017SE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC · Traditional | 01/03/2017SE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 05/24/2016SE |
| K122262 | Orthopat Advance Perioperative Autotransfusion SystemCAC · Traditional | 10/25/2012SE |
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Questions and answers
When was Haemonetics 600 Ml. Component Bag cleared by the FDA?
Haemonetics 600 Ml. Component Bag (K810711) received a 510(k) decision of Substantially Equivalent on May 8, 1981, 52 days after the submission was received.
What is the product code of K810711?
The FDA product code is KSR – Container, Empty, For Collection & Processing Of Blood & Blood Components, a Class II (moderate risk) device regulated under 21 CFR 864.9100.