RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS— 510(k) K060288
UnknownSpire Biomedical, Inc.
FDA 510(k) clearance K060288 for RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS, Unknown on 2006-09-01. 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
- Unknown
- 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.