FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K Number: K071998
·
Decision Sep 26, 2007
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
110
Review Days
65
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Basic Information
- Device Name
- ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K Number
- K071998
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrow Intl., Inc.
- Date Received
- July 23, 2007
- Decision Date
- September 26, 2007
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Arrow Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100635 | ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 | Aug 27, 2010 | Substantially Equivalent |
| K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | Dec 18, 2009 | Substantially Equivalent |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | Oct 10, 2007 | Substantially Equivalent |
| K071111 | NON-ABSORBABLE SILK SUTURE | Jul 17, 2007 | Substantially Equivalent |
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES | Apr 6, 2006 | Substantially Equivalent |
| K042126 | PICC | Aug 27, 2004 | Unknown |
| K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | Jul 12, 2004 | Substantially Equivalent |
| K040801 | INTRA-AORTIC BALLOON (IAB) | May 6, 2004 | Substantially Equivalent |
| K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR | Apr 28, 2004 | Substantially Equivalent |
| K040100 | ARROW ECHOGENIC INTRODUCER NEEDLE | Mar 1, 2004 | Substantially Equivalent |