Better-Bladder (BB)
FDA 510(k) K964337 · Circulatory Technology, Inc.
510(k) numberK964337
Submission
- Device name
- Better-Bladder (BB)
- Applicant
- Circulatory Technology, Inc.
Oyster Bay, NY, US - Received
- October 31, 1996
- Decision date
- May 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FIB – Protector, Transducer, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/28/2024SE |
| K072988 | Nipro Transducer Protector Tp-Sure, Model TPSURE+1FIB · Traditional | Nipro Medical Corporation | 02/21/2008SE |
| K001971 | Hemodialysis Tubing SetsFIB · Traditional | Ofi Biomedica S.P.A. | 05/24/2001SE |
| K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 04/27/2001SE |
| K001465 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 12/05/2000SE |
| K003445 | Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2FIB · Special | Fresenius Medical Care North America | 12/01/2000SE |
| K000702 | Borla Transducer Protector & Haemotronic Transducer ProtectorFIB · Traditional | Fresenius Medical Care North America | 06/07/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | Medisystems Corp. | 11/25/1998SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | Medisystems Corp. | 05/12/1997SE |
| K934069 | Millex, Dualex (Plus, Ultra)FIB · Traditional | Millipore Corp. | 04/21/1994SE |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K140321 | Initary Better Bladder-PediatricDTN · Special | 04/17/2014SE |
| K012942 | The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog…DTN · Traditional | 11/05/2001SE |
| K001822 | The V-BagDTN · Traditional | 07/07/2000SE |
| K981284 | Better-Bladder (BB)DTN · Traditional | 08/12/1998SE |
| K964205 | Better-TubingDWF · Traditional | 04/08/1998SE |
| K961594 | Better-VenterDWF · Traditional | 09/05/1996SE |
| K941492 | Pressure Relief ValveMNJ · Traditional | 10/26/1994SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | 08/25/1994SE |
Questions and answers
When was Better-Bladder (BB) cleared by the FDA?
Better-Bladder (BB) (K964337) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 204 days after the submission was received.
What is the product code of K964337?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.