Pall Gas Line Guardian Filter
FDA 510(k) K850327 · Pall Biomedical Products Co.
510(k) numberK850327
Submission
- Device name
- Pall Gas Line Guardian Filter
- Applicant
- Pall Biomedical Products Co.
Glen Cove, NY, US - Received
- January 28, 1985
- Decision date
- February 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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| K884534 | Pall Hepchek (TM) Heparin Absorption FilterJPA · Traditional | 01/24/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | 02/29/1988SE |
| K875094 | Ultipor Pre-Bypass Plus Filter W/Posidyne MembraneKRJ · Traditional | 02/29/1988SE |
| K873667 | Pall Leukocyte Removal Filter, PlateletsCAK · Traditional | 01/06/1988SE |
| K873666 | Pall Leukocyte Removal Filter, BloodCAK · Traditional | 01/06/1988SE |
| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | 12/30/1987SE |
Questions and answers
When was Pall Gas Line Guardian Filter cleared by the FDA?
Pall Gas Line Guardian Filter (K850327) received a 510(k) decision of Substantially Equivalent on February 26, 1985, 29 days after the submission was received.
What is the product code of K850327?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.