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FDA 510(k)

SWABBABLE CAP, MODEL 60205

K-Number: K070163 · 2007-08-03

ApplicantBaxa Corp.
Decision Date2007-08-03
Product CodeODI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SWABBABLE CAP, MODEL 60205 is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp.. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K070163. The device is classified under product code ODI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWABBABLE CAP, MODEL 60205?

SWABBABLE CAP, MODEL 60205 is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Baxa Corp.. The 510(k) number is K070163.

When did SWABBABLE CAP, MODEL 60205 receive FDA 510(k) clearance?

SWABBABLE CAP, MODEL 60205 received FDA 510(k) clearance on 2007-08-03, under 510(k) number K070163.

Who is the listed applicant for SWABBABLE CAP, MODEL 60205?

The FDA 510(k) record lists Baxa Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWABBABLE CAP, MODEL 60205?

The FDA product code for SWABBABLE CAP, MODEL 60205 is ODI.

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Other records listing Baxa Corp. 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.

K090917SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEMK062909REPEATER PUMP II TUBE SETSK022523RAPID-FILL TUBESET, MODEL 90005K002705EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400K983321MICROFUSE DUAL RATE INFUSERK951871PISTON SYRINGE

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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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