ARROW PERITONEAL LAVAGE CATHERIZATION K— 510(k) K811627
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K811627 for ARROW PERITONEAL LAVAGE CATHERIZATION K, Substantially Equivalent on 1981-08-10. Applicant: Arrow Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code GBW
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code GBW
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view all- K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
- K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
- K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES
- K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K071111 — NON-ABSORBABLE SILK SUTURE
Adverse events under product code GBW
product code GBW- Death
- 6
- Total
- 6
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 →
Recalls naming K811627
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K811627.
Data sourced from openFDA. This site is unofficial and independent of the FDA.