Atlas FDA

MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B

FDA 510(k) clearance K011395 · decided 2001-07-12

Clearance details

K-number
K011395
Device name
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2001-05-07
Decision date
2001-07-12
Days to decision
66 days
Clearance type
Special
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Vascular

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707)Corcym S.r.l.2026-06-18
TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498)Corcym S.r.l.2026-04-14
Seguin Annuloplasty Ring (K253232)ABBOTT MEDICAL2025-10-29
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982)Edwards Lifesciences, LLC2025-09-23
Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859)Genesee Biomedical, Inc.2025-07-25
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599)Genesee Biomedical, Inc.2024-04-09
WellsForm Tricuspid Annuloplasty Band (WF) (K230679)Genesee Biomedical, Inc.2023-05-26
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318)Corcym S.r.l.2023-04-07
TruForm Sievers Annuloplasty Ring (K202253)Genesee Biomedical, Inc.2020-10-06
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449)Medtronic, Inc.2020-07-01
Physio Flex Annuloplasty Ring (K192762)Edwards Lifesciences, LLC2019-12-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S094)Medtronic Vascular2026-06-05
RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S093)Medtronic Vascular2026-05-29
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S092)Medtronic Vascular2026-05-13
Endurant™ II/IIs Stent Graft System (P100021/S132)Medtronic Vascular2026-05-12
Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S090)Medtronic Vascular2026-03-25
Endurant™, Endurant™ II/lls Stent Graft System (P100021/S134)Medtronic Vascular2026-02-27
Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (P100040/S074)Medtronic Vascular2026-02-27
Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (P100021/S133)Medtronic Vascular2026-01-27