FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K Number: K000729
·
Decision May 19, 2000
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
110
Review Days
74
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Basic Information
- Device Name
- ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
- K Number
- K000729
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrow Intl., Inc.
- Date Received
- March 6, 2000
- Decision Date
- May 19, 2000
- Product Code
- DSP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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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 |
| K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT | Sep 26, 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 |