ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520— 510(k) K093050
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K093050 for ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520, Substantially Equivalent on 2009-12-18. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reading, PA, US
Recent devices under product code DQY
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
- K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES
- K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K071111 — NON-ABSORBABLE SILK SUTURE
- K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.