Apex(Tm) Prostatic Balloon Dilation Catheter
FDA 510(k) K913477 · Peripheral Systems Group
510(k) numberK913477
Submission
- Device name
- Apex(Tm) Prostatic Balloon Dilation Catheter
- Applicant
- Peripheral Systems Group
Mountain View, CA, US - Received
- August 5, 1991
- Decision date
- December 27, 1991
- 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 |
| K972964 | Atrion Medical Balloon Catheter Inflation DeviceKOE · Traditional | Atrion Medical Products, Inc. | 10/10/1997SE |
| 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 |
| K902585 | Uroplasty Tcu Prostatic Urethroplasty CatheterKOE · Traditional | Advanced Surgical Intervention, Inc. | 08/27/1990SE |
More from Advanced Surgical Intervention, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940804 | Smartneedle Vascular Access System, ModificationITX · Traditional | 06/10/1994SE |
| K934433 | Vantage Dialtaion CatheterLIT · Traditional | 12/09/1993SE |
| K932777 | Smartneedle(R) Over-The-Needle CatheterITX · Traditional | 10/07/1993SE |
| K931327 | PSG Directional Hydrophilic Guide WireDQX · Traditional | 07/14/1993SE |
| K915554 | Hi-Torque Sport-T(Tm) Guide WireDQX · Traditional | 02/09/1993SE |
| K914979 | Edm(R) Infusion CatheterKRA · Traditional | 09/16/1992SE |
| K913941 | Psg(Tm) 20 Guage Doppler NeedleITX · Traditional | 02/27/1992SE |
| K915168 | Proflex 5LIT · Traditional | 02/19/1992SE |
| K913746 | Smartneedle(Tm) Vascular Access SystemITX · Traditional | 12/17/1991SE |
| K904984 | Advance 418(TM)LIT · Traditional | 04/12/1991SE |
Questions and answers
When was Apex(Tm) Prostatic Balloon Dilation Catheter cleared by the FDA?
Apex(Tm) Prostatic Balloon Dilation Catheter (K913477) received a 510(k) decision of Substantially Equivalent on December 27, 1991, 144 days after the submission was received.
What is the product code of K913477?
The FDA product code is KOE – Dilator, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5520.