KENDALL CURITY SUCTION CATHETERS— 510(k) K892441
Substantially EquivalentThe Kendal Co.
FDA 510(k) clearance K892441 for KENDALL CURITY SUCTION CATHETERS, Substantially Equivalent on 1989-05-31. Applicant: The Kendal Co.. Device class: 1.
Clearance details
- Applicant
- The Kendal Co.
- Product code
- Code BSY
- Device class
- Class 1
- Regulation
- 21 CFR 868.6810
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code BSY
view allMore clearances from The Kendal Co.
view all- K000087 — MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
- K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
- K991758 — MONOJECT INSULIN SYRINGE
- K970969 — KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
- K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
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.