Atrion Medical Balloon Catheter Inflation Device
FDA 510(k) K972964 · Atrion Medical Products, Inc.
510(k) numberK972964
Submission
- Device name
- Atrion Medical Balloon Catheter Inflation Device
- Applicant
- Atrion Medical Products, Inc.
Arab, AL, US - Received
- August 11, 1997
- Decision date
- October 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOE – Dilator, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation CatheterKOE · Traditional | Urotronic, Inc. | 01/02/2020SE |
| K032840 | Atrion Medical QL Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 03/03/2004SE |
| K962611 | Bard Eagle Inflation DeviceKOE · Traditional | Ryder Intl. Corp. | 10/21/1996SE |
| K961904 | Aq Hydrophilic DilatorsKOE · Traditional | Cook Urological, Inc. | 10/18/1996SE |
| K924440 | U.S. Medical PS-7000 Dialysis ScaleKOE · Traditional | U.S. Medical Corp. | 05/26/1993SE |
| K920551 | 120 FR Optilume Prostate Balloon DilatorKOE · Traditional | American Medical Systems, Inc. | 10/28/1992SE |
| K922349 | Dowd(Tm) IIKOE · Traditional | Boston Scientific Corp | 08/14/1992SE |
| K920711 | Entrac Urethral Balloon Dilatation CatheterKOE · Traditional | American Medical Systems, Inc. | 05/06/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | Peripheral Systems Group | 12/27/1991SE |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty CatheterKOE · Traditional | Advanced Surgical Intervention, Inc. | 08/27/1990SE |
More from Advanced Surgical Intervention, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060643 | QL Locking SyringeMAV · Traditional | 07/12/2006SE |
| K043249 | Atrion Needlevise Large-Bore Sharps Securing DeviceFMI · Traditional | 05/25/2005SE |
| K041158 | Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing SystemCAZ · Traditional | 06/16/2004SE |
| K032840 | Atrion Medical QL Inflation DeviceKOE · Traditional | 03/03/2004SE |
| K020333 | Atrion Medical QL Fluid Dispensing SyringeDXT · Traditional | 04/25/2002SE |
| K973633 | Atrion Medical Products Lacrimal Intubation SetOKS · Traditional | 01/16/1998SE |
| K973872 | Atrion Medical Coated Lacrimal Intubation SetOKS · Traditional | 01/08/1998SE |
| K971100 | Atrion Medical Autogenous Tissue CollectorEIA · Traditional | 05/23/1997SE |
Questions and answers
When was Atrion Medical Balloon Catheter Inflation Device cleared by the FDA?
Atrion Medical Balloon Catheter Inflation Device (K972964) received a 510(k) decision of Substantially Equivalent on October 10, 1997, 60 days after the submission was received.
What is the product code of K972964?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.