FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUTOPLUS IV ADMINISTRATION SET
K Number: K990388
·
Decision Mar 29, 1999
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
49
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
- TUTOPLUS IV ADMINISTRATION SET
- K Number
- K990388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Myco Medical Supplies, Inc.
- Date Received
- February 8, 1999
- Decision Date
- March 29, 1999
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
iiSure Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
FDA 510(k)
FDA Class 2
·General Hospital
PuraCath Firefly Needleless Connector IT (9005)
FDA 510(k)
FDA Class 2
·General Hospital
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Pump Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
EZ IV Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Myco Medical Supplies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | Sep 29, 2021 | Substantially Equivalent |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | May 14, 2018 | Substantially Equivalent |
| K090426 | VAKU-8 BLOOD COLLECTION NEEDLES | Jun 12, 2009 | Substantially Equivalent |
| K042504 | CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER | Jan 19, 2006 | Substantially Equivalent |
| K000592 | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET | Apr 12, 2001 | Substantially Equivalent |
| K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | Jun 2, 2000 | Substantially Equivalent |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | Jun 2, 1999 | Substantially Equivalent |
| K982098 | TUTODROP 1 AND TUTODROP 2 | Mar 1, 1999 | Substantially Equivalent |
| K963364 | GLASS VAN GLASS SYRINGES | May 1, 1998 | Substantially Equivalent |
| K953252 | DISPOSABLE SCALP VEIN INFUSION SET | Nov 26, 1996 | Substantially Equivalent |