CATHETER MOUNTS— 510(k) K911421
Substantially EquivalentIntersurgical, Inc.
FDA 510(k) clearance K911421 for CATHETER MOUNTS, Substantially Equivalent on 1991-06-24. Applicant: Intersurgical, Inc.. Device class: 1.
Clearance details
- Applicant
- Intersurgical, Inc.
- Product code
- Code BZA
- Device class
- Class 1
- Regulation
- 21 CFR 868.5810
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cazenovia, NY, US
Recent devices under product code BZA
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- K121026 — FLO-GUARD BREATHING FILTER
- K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
- K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
Recalls naming K911421
K-number listed on FDA's recall record- Z-0786-2020 — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
- Z-0787-2020 — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911421.
Data sourced from openFDA. This site is unofficial and independent of the FDA.