FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADAPTER, CATHETER SHEATH
K Number: K781846
·
Decision Dec 12, 1978
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
110
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ADAPTER, CATHETER SHEATH
- K Number
- K781846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Arrow Intl., Inc.
- Date Received
- November 1, 1978
- Decision Date
- December 12, 1978
- Product Code
- KGZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGZ), ordered by most recent decision date.
AART SILICONE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WOUND DRAINAGE HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DURALASTIC SILICONE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAVARRE PERCUTANEOUS ACCESS SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALESTRANT IRRIGATION AND DRAINAGE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |