Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter— 510(k) K232130
Substantially EquivalentSurgical Instrument Services and Savings, Inc.
FDA 510(k) clearance K232130 for Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, Substantially Equivalent on 2023-12-15. Applicant: Surgical Instrument Services and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Services and Savings, Inc.
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
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More clearances from Surgical Instrument Services and Savings, Inc.
view allRecalls naming K232130
K-number listed on FDA's recall record- Z-1323-2026 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
- Z-2613-2025 — Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232130.
Data sourced from openFDA. This site is unofficial and independent of the FDA.