CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM— 510(k) K970264
Substantially EquivalentCordis Webster, Inc.
FDA 510(k) clearance K970264 for CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM, Substantially Equivalent on 1997-10-28. Applicant: Cordis Webster, Inc.. Device class: 2.
Clearance details
- Applicant
- Cordis Webster, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baldwin Park, CA, US
Recent devices under product code DYB
view allMore clearances from Cordis Webster, Inc.
view all- K992965 — CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
- K991531 — CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
- K982740 — CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
- K982415 — CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
- K980961 — CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.