15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS— 510(k) K060155
Substantially EquivalentSpire Biomedical, Inc.
FDA 510(k) clearance K060155 for 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS, Substantially Equivalent on 2006-05-09. Applicant: Spire Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Spire Biomedical, Inc.
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code MSD
view allMore clearances from Spire Biomedical, Inc.
view all- K073092 — DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
- K073093 — DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
- K063441 — 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
- K063431 — 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
- K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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.