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FDA 510(k)

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

K-Number: K901815 · 1990-07-03

ApplicantPioneering Technologies, Inc.
Decision Date1990-07-03
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY is the device name listed in this FDA 510(k) record. The listed applicant is Pioneering Technologies, Inc.. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K901815. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY?

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K901815.

When did MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY receive FDA 510(k) clearance?

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY received FDA 510(k) clearance on 1990-07-03, under 510(k) number K901815.

Who is the listed applicant for MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY?

The FDA 510(k) record lists Pioneering Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY?

The FDA product code for MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY is DRE.

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Other records listing Pioneering Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIFK905175PTI ANNULOPLASTY RING(STERILE)K905068PTI INTRA-ART (TM) PICK-UP WICKSK910067PTI STERNAL CLOSURE WIRE SUTUREK905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFTK901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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