DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR— 510(k) K073516
Substantially EquivalentKyphon, Inc.
FDA 510(k) clearance K073516 for DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR, Substantially Equivalent on 2008-02-21. Applicant: Kyphon, Inc.. Device class: 2.
Clearance details
- Applicant
- Kyphon, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code BSP
view allMore clearances from Kyphon, Inc.
view all- K063071 — DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
- K061210 — FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A; INTRODUCER NEEDLE, MODEL D01B
- K041454 — KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
- K041584 — KYPHX HV-R BONE CEMENT, MODEL C01A
- K033801 — KYPHX HV-R, MODEL C01A
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.