PNEUMOTHORAX KIT, MOTIFICATION— 510(k) K892640
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K892640 for PNEUMOTHORAX KIT, MOTIFICATION, Substantially Equivalent on 1989-10-11. Applicant: Arrow Intl., Inc.. Device class: 3.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Product code JDL
- Device class
- Class 3
- Regulation
- 21 CFR 888.3320
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code JDL
view allMore clearances from Arrow Intl., Inc.
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 JDL
product code JDL- Injury
- 285
- Total
- 285
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.